Label: ALOEMINT SKIN AID- menthol 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 July 21, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient               Purpose

    Menthol 0.31%                        topical analgesic ointment




  • INDICATIONS & USAGE

    Uses: Temporary relief of pain and itching associated with minor cuts and burns, scrapes, and insect bites.

  • WARNINGS AND PRECAUTIONS

    Warnings: For external use only.

    Avoid contact with the eyes.

    This product contains components that are flammable.  Keep away from fire or open flame.  Do not add this product to hot water.  Improper use may cause mixture to splatter and cause burns.


    Do not:

    use on wounds or damaged skin

    bandage tightly

  • ASK DOCTOR

    Stop using and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

    Children under 2 years of age: consult physician.

  • QUESTIONS


    Other information:

    To reorder call: 1-800-644-8327

    website: www.botanicchoice.com

    Use only of seal is unbroken

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Indiana Botanic Gardens, Inc.

    NDC# 1057800202

  • INACTIVE INGREDIENT

    Inactive ingredients: yellow petrolatum, natural lanolin (anhydrous), camphor, goldenseal powder, SDA alcohol, aloe vera juice concentrate, thyme oil

  • PRINCIPAL DISPLAY PANEL

    picture of label

  • INGREDIENTS AND APPEARANCE
    ALOEMINT SKIN AID 
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.31 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    THYME OIL (UNII: 2UK410MY6B)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10578-002-0257 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34801/01/1995
    Labeler - Indiana Botanic Gardens (005421771)
    Registrant - Indiana Botanic Gardens (005421771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Indiana Botanic Gardens005421771label, manufacture
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