Label: AGELESS PAIN RELIEF- methyl salicylate, menthol cream

  • NDC Code(s): 76187-762-02
  • Packager: Isagenix International, LLC
  • 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 December 22, 2017

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

  • ACTIVE INGREDIENT

    Active Ingredients                                    
    Methyl Salicylate 14.0%..............
    Menthol 7.0%.............................

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  • PURPOSE

    Purpose

    Topical Analgesic

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  • INDICATIONS & USAGE

    Uses  Temporarily receives the minor aches and pains of muscles and joints associated with: - simple backache  - anthrics  - strains - oruises - screms

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  • WARNINGS

    Warnings  For external use only

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  • ADVERSE REACTIONS

    Allergy Alert: If proris to allergic reaction to aspirin or salicylate, please consult a physician before use.

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  • DO NOT USE

    Do not use - on wounds or damaged skin - with a heating pad - on a child under 12 years of age with artricithtice conditions.

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  • ASK DOCTOR/PHARMACIST

    Ask a physician before use if you have rechess over the affected area.

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  • WHEN USING

    When using this product  - avoid contact with eyes cremuccus remembranes  - do not bandage highly.

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  • STOP USE

    Stop use and ask a physician if - condition worsons of symptoms persist for more than 7 days - symptons clear up and occur again within a few days  - excessive skin irritation occurs.

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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    Directions  - Use only as directed  - Adults and children over 12 years of ager. apply to affected area not more than 3 to 4 times daily. - children under 12 years of age: consult a physician.

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  • STORAGE AND HANDLING

    Other information  Store at 20 degree to 25 degree Centigrade (68 degree to 77 degree F).

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Glyceryl Stearate, Butylene Glycol, Glycerin, Polysorbate 80, Stearic Acid, Bezenyl Alcohol, dimethyl bullione (MSW), gluccsarmine silica, chondroitin sulfate, amica montena extract, allantain, caprylyl glycol, acrylated 10-80 alvon acrylate copolymer, smincernellyl proprol, phenoxyethanol, disodium EDTA.

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  • DESCRIPTION

    Ageless Pain Relief when applied topically provides temporary relef from joint pain associated with arthrits.  Non-Allergenic  Non-Sensinizing  Non-Greasy, Stainless  No Added Fragrance  Quick Absorption Move Freely  Ageless Pain Relief is a safe and effective non-narcotic topical pain relieving cream that can add in a wide variety of pain conditions including targeted. long-lastings relief from: - Joint pain - Muscle Pain - Simple Backache - Strains - Bruises  exclusively formulated for and distributed by: Isagenix International, LLC  2225 S. Price Rd., Chandier.AZ 85286  3900956762-00 Item #20056

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  • PRINCIPAL DISPLAY PANEL

    REJUVITY ISAGENIX  Ageless Pain Relief CREAM  A Menthol and methyl salicylate pain relieving cream with a Triple Combo Blend of natural ingredients: MSM, Glucosaming and Chondroitin.  Deep Penetrating Topical Analgesic  2 OZ

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  • PRINCIPAL DISPLAY PANEL

    LA12  EXP07/2012  exclusively formulated for and distributed by: Isagenix International, LLC  2225 S. Price Rd., Chandier.AZ 85286  3900956762-00 Item #20056

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  • INGREDIENTS AND APPEARANCE
    AGELESS PAIN RELIEF 
    methyl salicylate, menthol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76187-762
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 140 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 70 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76187-762-02 1 in 1 PACKAGE 12/19/2017
    1 60 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 04/23/2011
    Labeler - Isagenix International, LLC (144798480)
    Establishment
    Name Address ID/FEI Business Operations
    Englewood Lab, Inc. 080366903 manufacture(76187-762)
    Establishment
    Name Address ID/FEI Business Operations
    Englewood Lab Inc 690104005 manufacture(76187-762)
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