The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Petrolatum And Lanolin (NDC 59779-098). 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 ingredients PurposeLanolin 15.5%...................................Skin protectantPetrolatum 53.4%.............................Skin protectant
Otc - Purpose
Uses- helps treat and prevent diaper rash- temporarily protects minor: - cuts - scrapes - burns- temporarily protects and helps relieve chappedchaffed or cracked skin and lips- helps protect from the drying effects of wind andcold weather
Otc - Keep Out Of Reach Of Children
Keep out of 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- temporarily protects minor: - cuts - scrapes - burns- temporarily protects and helps relieve chappedchaffed or cracked skin and lips- helps protect from the drying effects of wind andcold weatherOther information- store between 20 degrees - 25 degrees C (68 degrees - 77 degrees F)
Warnings
Warnings For external use only. _______________________________Do not use on:- deep or puncture wounds- serious burns_______________________________When using this product- do not get into the eyes_______________________________Stop use and ask a doctor if:-condition worsens-symptoms last more than 7 days or clear up and occur again within a few days
Dosage & Administration
Directions-for skin protectional use: apply as needed- for diaper rash use: - change wet and soiled diapers promptly - cleanse the diaper area and 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 prolonged- for other uses: apply as needed________________________________Other informationStore between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
Inactive Ingredient
Inactive Ingredients cod liver oil (contains vitamin A and vitamin D), daucus carota sativa (carrot) seed oil, fragrance, microcrystaling wax, mineral oil, paraffin
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