OTC Medication Information: A and D

A AND D- petrolatum ointment
Safetec of America, 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.

Drug Facts

Active Ingredient

White Petrolatum 76 %

Purpose

Skin Protectant

Use

  • Temporarily protects minor:
    • cuts
    • scrapes
    • burns
  • Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips
  • Helps prevent and protect from the drying effects or wind and cold weather

Warnings

For external use only.

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product:

  • do not get into eyes

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.

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

Directions

Apply as needed

Other Information

Store at room temperature

  • Avoid excessive heat

Inactive Ingredients

Lanolin, Lavender Oil, Light Liquid Paraffin, Vitamin A, Vitamin D

Principal Display Panel –Tube Label

Safetec®

A&D Ointment

Skin Protectant with Vitamins A & D

Net Wt. 4oz. (113.4g)

Reorder No. 56001

Manufactured for: Safetec of America INC.

Buffalo, NY 14215 | 1-800-456-7077

Made in India KD/739

Principal Display Panel –Tube Label
(click image for full-size original)
A AND D
petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-4405
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
petrolatum (petrolatum) petrolatum 76 g in 100 g
Inactive Ingredients
Ingredient Name Strength
lanolin
lavender oil
LIGHT MINERAL OIL
VITAMIN A ACETATE
CHOLECALCIFEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61010-4405-1 113.4 g in 1 TUBE None
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)

Revised: 11/2019 Safetec of America, 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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