COTTONTAILS DIAPER RASH- lanolin, petrolatum paste

COTTONTAILS by

Drug Labeling and Warnings

COTTONTAILS by is a Otc medication manufactured, distributed, or labeled by AMERICAN SALES COMPANY, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

LANOLIN 15.5%

PETROLATUM 53.4%

PURPOSE

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. 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. SYMPTOMS LAST MORE THAN 7 DAYS. IF SYMPTOMS 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

OTHER INFORMATION

STORE BETWEEN 20°-25°C (68°-77°F)

INACTIVE INGREDIENTS

MICROCRYSTALLINE WAX, MINERAL OIL, PARAFFIN, FRAGRANCE (PARFUM), COD LIVER OIL (VITAMINS A & D)

QUESTIONS OR COMMENTS?

1-866-695-3030

LABEL COPY

INGREDIENTS AND APPEARANCE

COTTONTAILS  DIAPER RASH
lanolin, petrolatum paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-341
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	155 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	534 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
COD LIVER OIL (UNII: BBL281NWFG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-341-04	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/16/2013

Labeler - AMERICAN SALES COMPANY (809183973)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(41520-341)