Label: HEALTH SMART BLUE ICE TOPICAL ANALGESIC- menthol and camphor gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 21, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol             1.0%

    Camphor            0.5%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor pains and aches of your muscles and joints associated with:

    • Sports Injuries
    • Sprains
    • Arthritis
    • Bruises
  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes.

  • ASK DOCTOR

    Ask a doctor before use if you have cough associated with :

    • smoking
    • excessive phlegm
    • asthma
    • emphysema
    • persistent or chronic cough
  • WHEN USING

    When using this product, do not

    • heat
    • microwave
    • add to hot water or any container where heating water may cause splattering and result in burns
    • use in eyes or directly on mucous membranes
    • take by mouth or place in nostrils
    • apply to wounds or damaged skin
    • bandage skin
  • DO NOT USE

    Do not use with heating devices or pads.

  • STOP USE

    Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions: see important warnings under “When using this product”

    adults and children 2 years and over:

    • apply to the affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a physician.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aqua, Isopropyl Alcohol, Propylene Glycol, Carbopol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide , Disodium EDTA, Benzyl Alcohol, BHT & FD&C Blue No.1

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    HEALTH SMART BLUE ICE TOPICAL ANALGESIC GEL

    NET WT.8 OZ (227g)

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL



  • INGREDIENTS AND APPEARANCE
    HEALTH SMART BLUE ICE TOPICAL ANALGESIC 
    menthol and camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-017-27127 g in 1 TUBE; Type 0: Not a Combination Product08/01/2020
    2NDC:52862-017-28170 g in 1 TUBE; Type 0: Not a Combination Product08/01/2020
    3NDC:52862-017-21170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    4NDC:52862-017-29227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    5NDC:52862-017-30300 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    6NDC:52862-017-26500 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/02/2013
    Labeler - Home Smart Products (161872676)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52862-017)
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