Label: A AND D- petrolatum ointment
- NDC Code(s): 61010-4405-1
- Packager: Safetec of America, 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.
Updated November 1, 2019
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
For external use only.
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.
- Other Information
- Inactive Ingredients
- Principal Display Panel –Tube Label
INGREDIENTS AND APPEARANCE
A AND D
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-4405 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U) petrolatum 76 g in 100 g Inactive Ingredients Ingredient Name Strength lanolin (UNII: 7EV65EAW6H) lavender oil (UNII: ZBP1YXW0H8) LIGHT MINERAL OIL (UNII: N6K5787QVP) VITAMIN A ACETATE (UNII: 3LE3D9D6OY) CHOLECALCIFEROL (UNII: 1C6V77QF41) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-4405-1 113.4 g in 1 TUBE; Type 0: Not a Combination Product 11/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/01/2019 Labeler - Safetec of America, Inc. (874965262) Registrant - Safetec of America, Inc. (874965262)