OTC Medication Information: UP AND UP DIAPER RASH

UP AND UP DIAPER RASH- lanolin and petrolatum ointment
TARGET 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.

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 AND BURNS. TEMPORARILY PROTECTS AND RELIEVES 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

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

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS.

DO NOT USE ON

DEEP OR PUNCTURE WOUNDS, INFECTIONS OR LACERATIONS.

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.

OTHER INFORMATION

STORE BETWEEN 20-25C (58-77F).

INACTIVE INGREDIENTS:

COD LIVER OIL (VITAMIN A AND D), FRAGRANCE (PARFUM), LIGHT MINERAL OIL, MICROCRYSTALLINE WAX, PARAFFIN.

QUESTIONS?

CALL 1-800-910-6374.

LABEL COPY

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UP AND UP DIAPER RASH
lanolin, petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-340
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:11673-340-04 113.3 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 04/30/2012
Labeler — TARGET CORPORATION (006961700)
Registrant — APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture

Revised: 05/2012 TARGET CORPORATION

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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