Softi7.5%+30.5%

Softi is a topical barrier/emollient preparation used for the following indications:

Established use

• Topical protection and treatment of minor skin irritation, chafing, and diaper rash (nappy rash) in infants, by forming a protective barrier against moisture and friction.
• General skin protection in areas exposed to prolonged moisture, urine, or friction (e.g., in bedridden or incontinent patients), as an adjunct to routine skin care.

Adjunct use

• As an emollient to soothe and moisturize dry, chafed, or mildly irritated skin, used alongside proper hygiene and skin-care measures.

Softi is intended for minor, uncomplicated skin conditions; it is not a treatment for infected, fungal, or broken skin (see Precautions and Warnings).

Zinc Oxide + Virgin Castor Oil is a fixed-dose topical combination formulated as a cream or ointment. It contains:

• Zinc Oxide — the active skin-protectant ingredient, providing a physical barrier and mild astringent, mildly antiseptic action.
• Virgin (cold-pressed) Castor Oil — an emollient base ingredient that moisturizes and softens the skin and helps soothe irritation.

Exact concentrations of each ingredient may vary between manufacturers/brands of Zinc Oxide + Virgin Castor Oil; refer to the specific product label for the labeled strength.

Softi is a topical skin-protectant and emollient combination widely used in infant and general skin care. Zinc oxide forms an occlusive, protective film over the skin that shields it from moisture, urine, stool, and friction, while also providing mild astringent and mild antiseptic properties. Virgin castor oil complements this by acting as an emollient, moisturizing the skin, reducing dryness, and providing additional soothing effect.

Softi is available as a topical cream or ointment for external use and is most commonly used to prevent and manage diaper rash (nappy rash) and other forms of minor skin chafing or irritation.

Softi belongs to the therapeutic class of topical skin protectants and emollients (dermatological barrier preparations), used for external, non-systemic skin care.

Zinc Oxide + Virgin Castor Oil acts primarily through physical/barrier mechanisms rather than systemic pharmacologic action:

• Zinc oxide forms an insoluble, adherent film on the skin surface that physically blocks moisture, urine, and irritants from contacting the skin, and exerts a mild astringent effect that helps reduce local inflammation, along with mild antiseptic properties.
• Virgin castor oil, rich in ricinoleic acid, functions as an emollient that softens the stratum corneum, reduces transepidermal water loss, and provides a soothing, lubricating effect that complements the protective action of zinc oxide.

When applied topically to intact skin, Zinc Oxide + Virgin Castor Oil has negligible systemic absorption.

Apply Softi topically to clean, dry skin. Use only the amount needed to cover the affected area with a thin film. Do not apply to broken, weeping, or infected skin without medical advice, and do not apply near the eyes. For external use only; not for oral, ophthalmic, or internal use.

No clinically significant systemic drug-drug interactions have been established for Softi, owing to its topical use and minimal systemic absorption.

• Avoid applying other topical medicines to the same skin area at the same time as Softi without medical advice, as its occlusive barrier effect may reduce the penetration and effectiveness of other topical products.

Softi is generally well tolerated. Reported side effects are uncommon and typically mild, including:

• Local skin irritation, redness, or a mild burning/stinging sensation at the application site
• Allergic contact dermatitis (rash, itching, swelling) in sensitive individuals
• Staining of clothing or bedding due to the oily base

Discontinue use of Softi and seek medical advice if signs of an allergic reaction or worsening irritation occur (see Precautions and Warnings).

Softi is applied topically with minimal systemic absorption, and is generally considered low risk when used as directed during pregnancy and breastfeeding. However, as with any topical product, it should be used only if clearly needed, and pregnant or breastfeeding women should consult a physician or pharmacist before use, particularly for use over large areas of skin or for prolonged periods. If used during breastfeeding, avoid application directly on/around the nipple area unless advised by a physician.

Softi is for external use only.

• Avoid contact with the eyes; if accidental contact occurs, rinse thoroughly with water.
• Discontinue use and consult a physician if signs of skin irritation, rash, or allergic reaction develop.
• Do not apply Softi to broken, weeping, or infected skin without medical guidance.
• If diaper rash or skin irritation is persistent, worsening, or shows signs of infection (e.g., spreading redness, pus-filled bumps/pustules, or fever), seek medical evaluation promptly rather than relying on Softi alone, as these signs may indicate a fungal or bacterial infection requiring specific treatment.
• Keep out of reach of children; not intended for ingestion.

Significant overdose is unlikely with the intended topical use of Softi. If accidentally ingested, particularly by a child, mild gastrointestinal upset (e.g., nausea, vomiting) may occur. In case of accidental ingestion or a large accidental application with concerning symptoms, seek immediate medical attention or contact a poison control center/emergency services rather than attempting home treatment.

Store at room temperature (below 30°C), away from light and moisture. Keep the container tightly closed and out of reach of children.

Infants and children: Softi is commonly used in infants for prevention and treatment of diaper rash; use as directed and consult a pediatrician for persistent or severe rash.

Elderly/bedridden or incontinent patients: may be used as a barrier preparation to protect skin exposed to prolonged moisture or friction, as part of routine skin care.

Pregnancy and lactation: see Pregnancy and Lactation section above.

Hepatic/renal impairment: not applicable, given negligible systemic absorption with topical use of Softi.

Softi may be used as needed for as long as symptoms of minor skin irritation or diaper rash persist. If there is no improvement within 7 days, or if the condition worsens, use should be discontinued and a physician consulted.

Topical skin protectant; emollient (dermatological barrier preparation).

Zinc Oxide + Virgin Castor Oil works mainly via a physical/barrier mode of action rather than a receptor-mediated pharmacologic effect. Zinc oxide forms a protective, occlusive layer on the skin that blocks moisture and irritants and provides mild astringent and antiseptic activity, while virgin castor oil acts as an emollient that softens and moisturizes the skin, enhancing the barrier's comfort and effectiveness.

Softi is commonly and widely used in infants, including newborns, for prevention and management of diaper rash and minor skin irritation, applied topically as directed. As with any topical product used in infants, apply only the amount needed, avoid the eyes and mouth, and discontinue use and consult a pediatrician if irritation, rash, or signs of infection develop. Formal systemic safety/efficacy studies (as required for systemically absorbed drugs) are not applicable given its topical, barrier mode of action, but its use for diaper rash in infants is a long-established and widely accepted skin-care practice.