Label: A AND D FIRST AID- lanolin and petrolatum ointment
- NDC Code(s): 11523-7204-1
- Packager: Bayer HealthCare LLC
- 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 September 8, 2023
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 42.5 g Carton
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INGREDIENTS AND APPEARANCE
A AND D FIRST AID
lanolin and petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7204 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 136.4 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 469.9 mg in 1 g Inactive Ingredients Ingredient Name Strength COD LIVER OIL (UNII: BBL281NWFG) LIGHT MINERAL OIL (UNII: N6K5787QVP) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PARAFFIN (UNII: I9O0E3H2ZE) Product Characteristics Color orange (Unctuous amber mass) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-7204-1 1 in 1 CARTON 06/04/2003 04/20/2023 1 42.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/04/2003 Labeler - Bayer HealthCare LLC (112117283)