Label: ACTIVE HYDROGEN PROFESSIONAL CREAM- menthol cream

  • 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 24, 2022

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

  • Warnings

    • For external use only
    • When using this product

    • use only as directed

    • do not bandage or use with heating pad or medicated patch

    • avoid contact with eyes and mucous membranes

    • do not apply to open wounds or damaged, broken or irritated skin

    • a slight burning may occur upon application with disappearing effect in short period of time

  • ACTIVE INGREDIENT

  • Purpose

    Topical analgesic

  • Uses

    Reduces and stops the inflammatory process, eliminates pain, reduces swelling, speeds up
    recovery process after injuries, neutralizes excretion of lactic acid in the muscles

  • Directions

    adults and children over 12 years:
    • apply a thin layer to the target - the sore spot
    • massage into painful area until thoroughly absorbed into skin

    • repeat the process one again.

    • repeat the process minimum 3 times per day 

    Children 12 years or younger: ask a doctor

  • KEEP OUT OF REACH OF CHILDREN

    If preganant or breast-feeding, ask a health professional before use.

    Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away

    Use within 90 days after opening the product.

  • Stop use and ask doctor if

    • condition worsens

    • redness is present

    • irritation develops
    • symptoms persist for more then 7 days or clear up and occur again within a few days

  • Inactive Ingredients

    Ascorbic Acid, Aqua, Boric Acid, Butylated Hydroxytoluene, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Ethylhexanoate, Disodium Edta, Glycerol, Glyceryl Stearate (and) Ceteareth-20 (and) Ceteareth-12 (and) Cetearyl Alcohol (and) Cetyl Palmitate, Magnesium Oxide, Paraffinum Liquidum, Perfume, Phenoxyethanol (and) Ethylhexylglycerin, Propylene Glycol, Tocopheryl Acetate.

  • Product label

    image descriptionimage descriptionimage description

  • INGREDIENTS AND APPEARANCE
    ACTIVE HYDROGEN PROFESSIONAL CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72901-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BORIC ACID (UNII: R57ZHV85D4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72901-002-011 in 1 CARTON03/28/2019
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/28/2019
    Labeler - 8.0 IDEAL BALANCE D.O.O. BEOGRAD (506132408)