Label: AQUAPHOR ORIGINAL- petrolatum ointment
- NDC Code(s): 10356-100-37
- Packager: Beiersdorf Inc
- 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 November 14, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- QUESTIONS
- DOSAGE & ADMINISTRATION
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PRINCIPAL DISPLAY PANEL
Aquaphor Original Ointment
Severly Dry Skin Treatment
Clinically proven to restore smooth, healthy skin
Preservative and Fragrance Free
Skin Protectant
Dermatologist recommended
For the pharmacist: Aquaphor provides an ideal base for compounding smooth, stable emulsions.
It is highly miscible with aqueous solutions as well as oil-based substances.
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INGREDIENTS AND APPEARANCE
AQUAPHOR ORIGINAL
petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10356-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 41 g in 100 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) CERESIN (UNII: Q1LS2UJO3A) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10356-100-37 396 g in 1 JAR; Type 0: Not a Combination Product 06/01/1975 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/01/1975 Labeler - Beiersdorf Inc (001177906)