Label: MAXXIMA- camphor and menthol lotion

  • 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 June 11, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients

    Camphor 3.01%

    Menthol 1.25%

  • PURPOSE

    Purpose

    Topical analgesic

    Topical analgesic

  • INDICATIONS & USAGE

    Usesfor temporary relief of minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • sprains
    • bruises
  • WARNINGS

    Warnings

    For external use only

    Do not use

    • on children under 10 years of age
    • on wounds or damaged skin

    When using this product

    • use only as directed
    • do not bandage tightly
    • avoid contact with eyes and open sores

    Stop use and ask doctor if

    • excessive redness or skin irritation is present
    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breastfeeding, ask a health professional before use.

  • 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.

  • STORAGE AND HANDLING

    Other Information

    store between 15 degrees and 30 degrees C (59 degrees to 86 degrees F)

  • DOSAGE & ADMINISTRATION

    Directions

    • Shake well before use
    • Adults and children 10 years of age and older:
      • apply to affected area not more than 3-4 times daily
      • massage lightly into painful areas until thoroughly absorbed into the skin
    • Children under 10 years of age consult a physician
  • INACTIVE INGREDIENT

    Inactive ingredients

    glycerin, water, hydroxypropylmethylcellulose, propylene glycol, aloe vera extract, lavender oil, tea tree oil, spruce oil, rosemary oil, sage oil, juniper berry oil, cajeput oil, peppermint oil, horse chestnut extract, methyl paraben, sodium copper chlorophyllin, propyl paraben

  • QUESTIONS

    Manufactured for: Dr. Knoll Products, Inc.

    374 Newton Street, P.O. Box 116, Canfield, OH 44406

    TO REORDER: 1-800-2434

  • PRINCIPAL DISPLAY PANEL

    Maxxima 

    The Pain Relieving Cream

    External Analgesic

    with Camphor and Menthol

    With Moisturizing Aloe

     fl oz ( ml)

    For your protection, this bottle has an imprinted seal around the neck. 

    4oz Maxxima Label

    2oz Maxxima Label

  • INGREDIENTS AND APPEARANCE
    MAXXIMA 
    camphor and menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50638-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.01 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PICEA MARIANA LEAF OIL (UNII: Q1J49L1A5O)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SAGE OIL (UNII: U27K0H1H2O)  
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50638-100-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2012
    2NDC:50638-100-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/11/2012
    Labeler - Dr. Knoll Products, Inc. (121880975)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vita-Herb Nutriceuticals, Inc.053760034manufacture(50638-100)
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