Label: THERACARE PETROLEUM JELLY- white petrolatum jelly
- NDC Code(s): 71101-208-01
- Packager: Veridian Healthcare
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 1, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Inactive Ingredients
- TheraCare Petroleum Jelly
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INGREDIENTS AND APPEARANCE
THERACARE PETROLEUM JELLY
white petrolatum jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71101-208 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 100 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71101-208-01 113 g in 1 JAR; Type 0: Not a Combination Product 02/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/01/2022 Labeler - Veridian Healthcare (830437997) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Private Limited 726025211 manufacture(71101-208)