LUCKY SUPERSOFT MUSCLE AND JOINT (CAMPHOR MENTHOL METHYL SALICYLATE) CREAM [DELTA BRANDS INC]

LUCKY SUPERSOFT MUSCLE AND JOINT (CAMPHOR MENTHOL METHYL SALICYLATE) CREAM [DELTA BRANDS INC]
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NDC 20276-106-42
Set ID 9c6b5a7b-fa69-46df-b66a-add48b380d63
Category HUMAN OTC DRUG LABEL
Packager Delta Brands Inc
Generic Name
Product Class
Product Number
Application Number PART348
  • 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:20276-106
    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:20276-106-4242.5 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 - Delta Brands Inc (102672008)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(20276-106)

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