OTC Medication Information: VITAMINS A AND D DIAPER RASH

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.

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).

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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
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

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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