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Name:Vitamins A And D Diaper Rash
Manufacturer:Rite Aid
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

VITAMINS A AND D DIAPER RASH   - lanolin and petrolatum ointment 
RITE AID

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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DRUG FACTS

ACTIVE INGREDIENT

LANOLIN 15.5 PERCENT

PETROLATUM 53.4 PERCENT

PURPOSE

SKIN PROTECTANT

SKIN PROTECTANT

USES

HELPS TREAT AND PREVENT DIAPER RASH.

TEMPORARILY PROTECTS MINOR: CUTS SCRAPES BURNS.

TEMPORARILY PROTECTS AND RELIEVES CHAPPED, CHAFE 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

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.


STOP USING THIS PRODUCT AND ASK 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 REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

FOR SKIN PROTECTANT USE APPLY AS NEEDED

FOR DIAPER RASH USE

    CHANGE WET AND SOILED DIAPERS PROMPTLY

     CLEAN THE DIAPER AREA, AND ALLOW TO DRY

     APPLY OINTMENT AS OFTEN AS REQUIRED, WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE 

     PROLONGED.

INACTIVE INGREDIENTS

COD LIVER OIL, FRAGRANCE, LIGHT MINERAL OIL, MICROCRYSTALLINE WAX, PARAFFIN.

QUESTIONS OR COMMENTS

1-866-695-3030

OTHER INFORMATION

STORE BETWEEN 20 DEGREES CELSIUS TO 25 DEGREES CELSIUS (68 DEGREES FAHRENHEIT TO 77 DEGREES FAHRENHEIT).

IMAGE OF RA1


VITAMINS A AND D DIAPER RASH  
lanolin and petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-3401
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      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-3401-6 454 g in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 01/04/2011

Labeler - RITE AID (014578892)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture

Revised: 01/2011 RITE AID



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


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