Label: LUCKY SUPERSOFT MUSCLE AND JOINT- camphor menthol methyl salicylate 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 December 20, 2020

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  • Active ingredients

    Camphor 4%

    Menthol 10%

    Methyl Salicylate 30%

  • Purpose

    Topical analgesic

    Topical analgesic

    Topical analgesic

  • Uses

    temporarily relieves the minor aches and pains of muscles and joints associated with :

    ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

  • Warnings

    For external use only

  • Do not use

    ■ on wounds or damaged skin ■ with a heating pad

    ■ on a child under 12 years of age with arthritis like conditions

  • When using this product

    ■ avoid contact with eyes or mucous membranes ■ do not bandage tightly

  • Stop use and ask a doctor if

    ■ condition worsens, or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days

    ■ excessive skin irritation occurs

  • Keep out of reach of children

    to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    ■ use only as directed ■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 time daily

    ■ children under 12 years of age: ask a doctor

  • Other information

    ■ store between 20 to 25C (68 to 77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

  • Inactive ingredients

    carbomer 940, edetate disodium, glyceryl stearate se, lanolin, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

  • Package Label

    Package Labelimage description

  • INGREDIENTS AND APPEARANCE
    LUCKY SUPERSOFT  MUSCLE AND JOINT
    camphor menthol methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    LANOLIN (UNII: 7EV65EAW6H)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47046-177-0142.5 g in 1 TUBE; Type 0: Not a Combination Product01/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/31/2015
    Labeler - Anicare Pharmaceuticals Pvt. Ltd. (916837425)
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