The following Structured Product Label (SPL) was submitted to the FDA by Riteaid Corporation for the product Rite Aid Diaper Rash (NDC 11822-0376). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active ingredient PurposeZinc Oxide. 40%.......................................Skin protectant
Otc - Purpose
Uses- helps treat and prevent diaper rash- protects chafed skin due to diaper rash and helps seal out wetness
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Uses- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash and helps seal out wetness
Warnings
Warnings For external use only. When using this product - do not get into eyesStop use and ask a doctor if:- condition worsens - symptoms last more than 7 days or clearup and occur again within a few days.Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions- change wet and soiled diapers promptly - cleanse the diaper area- allow to dry- apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolongedOther informationStore at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
Inactive Ingredient
Inactive IngredientsBHA, cod liver oil, fragrance, lanolin, methylparaben, petrolatum, purified water, talc
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