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Name:Vitamins A And D
Manufacturer:Qualitest Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


Vitamins A and D Ointment

VITAMINS A AND D - lanolin and petrolatum ointment 
Qualitest Pharmaceuticals

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.

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Vitamins A and D Ointment

Active ingredients

Lanolin 15.5%

Petrolatum 53.4%

Purpose

Skin Protectant

Skin Protectant

Uses

  • helps treat and prevent diaper rash
  • temporarily protects minor:
    • cuts
    • scrapes
    • burns
  • temporarily protects and helps relieve chapped, chafed or cracked skin and lips
  • helps protect from the drying effects of wind and cold weather

Warnings

For external use only

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

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

  • for skin protectant use apply as needed
  • for diaper rash use:
    • change wet and soiled diapers promptly
    • cleanse the diaper area, and allow to dry
    • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

  • store at 15° to 30°C (59° to 86°F)
  • lot number and expiration date: see crimp of tube or see box

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

cod liver oil (contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 2/10 R4
8277869 0410

PRINCIPAL DISPLAY PANEL

This is an image of the Vitamins A & D Ointment Carton.

VITAMINS A AND D 
lanolin and petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0410
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANOLIN (LANOLIN) LANOLIN 15.5 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM 53.4 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
COD LIVER OIL  
LIGHT MINERAL OIL  
MICROCRYSTALLINE WAX  
PARAFFIN  
Product Characteristics
Color YELLOW (yellowish) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-0410-54 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
1 113 g in 1 TUBE This package is contained within the CARTON (0603-0410-54)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 07/01/1996

Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
Name Address ID/FEI Operations
Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE

Revised: 12/2010 Qualitest Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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