OTC Medication Information: A and D

A AND D- petrolatum ointment
Henry Schein, Inc.

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.

White petrolatum 93.5%

Purpose: Skin protectant

Uses: Temporarily protects minor: cuts, scrapes, burns. Temporarily protects and helps chapped or cracked skin and lips. Helps protect lips from drying effects of wind and cold weather.

Warnings: For external use only. Stop use and ask a doctor if: condition worsens, symptoms last for more than 7 days or clear up and occur again within a few days. Do not use on: deep or puncture wounds, animal bites, serious burns

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Apply as needed.

Inactive ingredients: Corn oil, light mineral oil, vitamin A palmitate, vitamin D.

A AND D petrolatum ointment

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-0375 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (PETROLATUM) PETROLATUM 937.5 mg in 1 g

Inactive Ingredients Ingredient Name Strength VITAMIN A PALMITATE ERGOCALCIFEROL CORN OIL LIGHT MINERAL OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0404-0375-47 144 PACKET in 1 CARTON contains a PACKET (0404-0375-05) 1 NDC:0404-0375-05 5 g in 1 PACKET This package is contained within the CARTON (0404-0375-47)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/04/2011

Labeler — Henry Schein, Inc. (012430880)

Registrant — ULTRAtab Laboratories, Inc. (151051757)

Establishment
Name	Address	ID/FEI	Operations
Ultra Seal Corporation		085752004	pack (0404-0375)

Revised: 10/2019 Henry Schein, Inc.