OTC Medication Information: Vitamin A and D

VITAMIN A AND D- petrolatum ointment
Medline Industries, LP

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.

Active Ingredient (in each gram)

Petrolatum 93.5%

Purpose

Skin Protectant

Uses

  • temporarily protects and relieves
  • minor cuts
  • scrapes
  • burns
  • chapped or cracked skin and lips

Warnings

  • for external use only

Stop use and consult a doctor if

  • condition worsens
  • if symptoms last for more than 7 days or clear up and occur again within a few days

When using this product

  • avoid contact with eyes

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

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 controlled room temperature 68- 77 ºF (20-25 ºC)
  • Use only if packaging is intact.

Inactive ingredients

corn oil, light mineral oil, vitamin A palmitate, vitamin D

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Manufactured in USA of foreign and domestic materials

www.curad.com

1-800-633-5463

REF: CUR003501

V1 RC22ULI

Package Label

Label V1 RC22ULI
(click image for full-size original)

VITAMIN A AND D
skin protectant ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-090
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 935 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
LIGHT MINERAL OIL
VITAMIN A PALMITATE
VITAMIN D
CORN OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53329-090-14 1 TUBE in 1 BOX contains a TUBE
1 56.6 g in 1 TUBE This package is contained within the BOX (53329-090-14)
2 NDC:53329-090-96 144 PACKET in 1 CARTON contains a PACKET (53329-090-16)
2 NDC:53329-090-16 5 g in 1 PACKET This package is contained within the CARTON (53329-090-96)
3 NDC:53329-090-16 5 g in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final M016 03/01/2010 12/31/2024
Labeler — Medline Industries, LP (025460908)

Revised: 06/2023 Medline Industries, LP

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.

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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