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.

HSADPACKETCARTON

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.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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