Otc - Active Ingredient
Active ingredient PurposeWhite petrolatum60.4%......................................Skin protectant
Petrolatum
FDA Label NDC 59779-148
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Petrolatum (NDC 59779-148). 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.
Label Section Quick Index
Otc - Purpose
Active ingredient PurposeSalicylic Acid (0.5%)..............................Acne Medication______________________________________Use for the management of acne
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 immediately.
Indications & Usage
Uses- helps prevent and treat diaper rash- helps seal out wetness and protectschafed skin due to diaper rash-gives temporary relief to chapped,cracked skin- offers protection from the dryingeffects of wind and cold weather- gives temporary protection for minorcuts, scrapes and burns
Warnings
Warnings For external use only. _______________________________Do not use on:- puncture wounds or deep wounds- animal bites - serious burns_______________________________Keep product away from eyes._______________________________Stop use and ask a doctor if:-condition worsens-symptoms last more than 7 days; clearup and occur again within several days
Dosage & Administration
Directions-for diaper rash: - change soiled, wet diapers immediately - cleanse diaper area thoroughly and allow to dry - liberally apply ointment as often as necessary, with each diaper change, especially at bedtime or whenever exposure to wet diapers may be prolonged- for other uses: apply as needed________________________________Other informationStore at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
Inactive Ingredient
Inactive Ingredientscholecalciferol, cocoa butter, fragrance,light mineral oil, mineral oil, modified lanolin, paraffin, sodium pyruvate,sunflower seed oil, Vitamin A palmitate,Vitamin E (di-alpha tocopherol and di-alpha tocopheryl acetate)
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