Label: FIRST AID RESEARCH CHAFE AWAY MEDICATED HEALING- menthol and zinc oxide ointment

  • 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 January 1, 2013

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients                                                                    Purpose

    Menthol 0.44% .......................................................................External analgesic, first aid antiseptic

    Zinc Oxide 20% .....................................................................Skin protectant/moisture barrier

  • PURPOSE

    Uses

    • A moisture barrier that helps prevent and relieve chafed, chapped or cracked skin
    • Helps protects from drying effects of wind and cold weather
    • Temporarily provides a soothing and protective coating over inflamed and painful tissue
  • WARNINGS

    Warning

    For external use only

    Not for deep or puncture wounds, avoid contact with eyes

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of accidental ingestion contact a physician or Poison Control Center immediately.

  • INDICATIONS & USAGE

    Directions

    • cleanse skin gently with mild skin cleanser
    • pat dry or allow to air dry
    • apply a thin layer of ointment to redened or irritated skin 2-4 times per day
  • STORAGE AND HANDLING

    Other information

    • Store at 20o to 25oC (68o to 77oF)
    • Lot No. and Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Vera Gel, Butylated Hydroxytoluene, Calamine, Ergocalciferol, Liquid Paraffin, Methylparaben, Purified Lanolin, Purified Water, Retinol Palmitate, Tocopherol Acetate, Trolamine, White Petrolatum

  • DOSAGE & ADMINISTRATION

    Distributed by:

    First Aid Research Corp.

    3375 Park Ave. Suite 2003

    Wantagh, NY 11793 USA

    www.firstaidresearch.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    FIRST AID RESEARCH CHAFE AWAY MEDICATED HEALING 
    menthol and zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75983-738
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.44 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ERGOCALCIFEROL (UNII: VS041H42XC)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LANOLIN (UNII: 7EV65EAW6H)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75983-738-571 in 1 CARTON
    157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2013
    Labeler - FIRST AID RESEARCH CORP. (089405927)
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!