COTTONTAILS DIAPER RASH- lanolin, petrolatum paste 
AMERICAN SALES COMPANY

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 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

IMAGE OF THE LABEL

COTTONTAILS  DIAPER RASH
lanolin, petrolatum paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-341
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN155 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM534 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
COD LIVER OIL (UNII: BBL281NWFG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-341-04113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/16/2013
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41520-341)

Revised: 12/2013
Document Id: e5c46712-ee67-4760-84b4-818488718644
Set id: 5b7e6ddb-78fa-48bc-9ac2-de5c6b909aac
Version: 1
Effective Time: 20131217
 
AMERICAN SALES COMPANY