TRIPLE ACTION ARTHRITIS (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [WONG CHARKKEN BILL]

TRIPLE ACTION ARTHRITIS (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [WONG CHARKKEN BILL]
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NDC 71049-101-12
Set ID 9fd0f54a-30bb-41d1-84db-7b1be738644d
Category HUMAN OTC DRUG LABEL
Packager WONG CHARKKEN BILL
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENTS

    METHYL SALICYLATE 28%

    MENTHOL 10%

    CAPSAICIN 0.025%

  • PURPOSE

    TOPICAL ANALGESIC

  • USES

    FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH:

    • ARTHRITIS
    • SPRAINS
    • STRAINS
    • BRUISES
    • SIMPLE BACKACHE
  • WARNINGS

    FOR EXTERNAL USE ONLY.

    • USE ONLY AS DIRECTED
    • DO NOT GET INTO EYES OR MUCOUS MEMBRANES
    • DO NOT APPLY TO WOUNDS OR DAMAGED, BROKEN OR IRRITATED SKIN
    • DO NOT TIGHTLY WRAP OR BANDAGE
    • DO NOT USE WITH A HEATING PAD
    • DO NOT EXPOSE THE TREATED AREA TO EXTERNAL HEAT OR DIRECT SUNLIGHT
    • A BURNING SENSATION MAY OCCUR UPON APPLICATION BUT GENERALLY DISAPPEARS IN A FEW DAYS WITH REGULAR USE
  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    • CONDITION WORSENS
    • EXCESSIVE BURNING OR IRRITATION PERSISTS
    • PAIN PERSISTS FOR MORE THAN 7 DAYS
    • SYMPTOMS CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS
  • PREGNANCY OR BREAST FEEDING

    IF PREGNANT OR BREAST FEEDING, 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

  • DIRECTIONS:

    ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER

    • APPLY TO THE AFFECTIVE AREA AND GENTLY RUB IT IN UNTIL FULLY ABSORBED
    • REPEAT AS NECESSARY, BUT NOT MORE THAN 3 TO 4 TIMES DAILY
    • UNLESS TREATING HANDS, WASH HANDS THOROUGHLY WITH SOAP AND WATER IMMEDIATELY AFTER USE

    CHILDREN UNDER 12

    • CONSULT A DOCTOR
  • OTHER INFORMATION:

    STORE AT ROOM TEMPARATURE

  • INACTIVE INGREDIENTS

    Acrylates/C10-30alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Benzoic Acid, Boswellia Serrata Gum, Cetear yl Alcohol, Ethylhexylglycerin, Gaultheria Procumbens (Wintergreen) Leaf Extract, Glycereth-2 Cocoate, Glycer yl Stearate, Hydroxypropyl
    Methyl Cellulose, Isopropyl Palmitate, Peg-100 Stearate, Petasites Vulgaris Leaf Extract, Phenoxyethanol, Polysorbate 60, Propylene Glycol, Salix Alba (Willow) Bark Extract, Stearyl Alcohol, Zanthoxylum Americanum Bark Extract, Pinus Pinaster Bark/Bud Extract, Water, Zingiber
    Officinale (Ginger) Root Extract.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    TRIPLE ACTION ARTHRITIS 
    methyl salicylate, menthol, capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71049-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE28 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PETASITES HYBRIDUS LEAF (UNII: JOS311ZC1G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)  
    PINUS PINASTER WHOLE (UNII: J27867F361)  
    WATER (UNII: 059QF0KO0R)  
    ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71049-101-1260 g in 1 JAR; Type 0: Not a Combination Product10/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/22/2016
    Labeler - WONG CHARKKEN BILL (047390480)

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