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Name:Vitamin A D
Manufacturer:Dynarex Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Vitamin A D

VITAMIN A D   - petrolatum ointment 
Dynarex Corporation

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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Vitamin A D

Active Ingredient                               Purpose

White Petrolatum USP (76%)            Skin Protectant

Uses:

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor * cuts * scrapes * burns
  • Temporarily helps protect and help relieve chapped and cracked skin and lips
  • Helps prevent and protect from the drying effects of wind and cold weather
  • Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
  • With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged

Warnings:

For External Use Only

When using this product:

  • Do not get in eyes

Stop use and ask a doctor if:

  • If condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days

Do not use on:

Do not use on:
  • Deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions for diaper rash:

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply as needed

Other information:

  • Store at room temperature 15 deg C to 30 deg C    59 deg F to 86 deg F
  • Avoid excessive heat

Principal Display Panel

Vitamin A-D Ointment

Vitamin_A_D


VITAMIN A D  
vitamin a d ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-214
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM .76 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
VITAMIN A PALMITATE  
CHOLECALCIFEROL  
LANOLIN  
LAVENDER  
LIGHT MINERAL OIL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67777-214-01 12 BOX ( BOX) in 1 CASE contains a BOX
1 6 TUBE ( TUBE) in 1 BOX This package is contained within the CASE (67777-214-01) and contains a TUBE
1 113.4 g in 1 TUBE This package is contained within a BOX and a CASE (67777-214-01)
2 NDC:67777-214-02 12 JAR ( JAR) in 1 CASE contains a JAR
2 425.25 g in 1 JAR This package is contained within the CASE (67777-214-02)
3 NDC:67777-214-03 72 TUBE ( TUBE) in 1 CASE contains a TUBE
3 28.35 g in 1 TUBE This package is contained within the CASE (67777-214-03)
4 NDC:67777-214-04 72 BOX ( BOX) in 1 CASE contains a BOX
4 1 TUBE ( TUBE) in 1 BOX This package is contained within the CASE (67777-214-04) and contains a TUBE
4 28.35 g in 1 TUBE This package is contained within a BOX and a CASE (67777-214-04)
5 NDC:67777-214-05 72 TUBE ( TUBE) in 1 CASE contains a TUBE
5 56.7 g in 1 TUBE This package is contained within the CASE (67777-214-05)
6 NDC:67777-214-06 72 BOX ( BOX) in 1 CASE contains a BOX
6 1 TUBE ( TUBE) in 1 BOX This package is contained within the CASE (67777-214-06) and contains a TUBE
6 56.7 g in 1 TUBE This package is contained within a BOX and a CASE (67777-214-06)
7 NDC:67777-214-07 72 BOX ( BOX) in 1 CASE contains a BOX
7 1 TUBE ( TUBE) in 1 BOX This package is contained within the CASE (67777-214-07) and contains a TUBE
7 113.4 g in 1 TUBE This package is contained within a BOX and a CASE (67777-214-07)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 03/24/2010

Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
Name Address ID/FEI Operations
Galentic Pharma India Private Limited 918531450 manufacture
Establishment
Name Address ID/FEI Operations
Choice Laboratories 650070394 manufacture

Revised: 06/2010 Dynarex Corporation



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


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