Label: COTTONTAILS DIAPER RASH- lanolin, petrolatum paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 17, 2013

If you are a consumer or patient please visit this version.

View All Sections
  • 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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!