Label: COLD AND HEAT PAIN RELIEVING CREAM- menthol and methyl salicylate cream

  • NDC Code(s): 72351-010-00
  • Packager: SOTAC PHARMACEUTICALS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL

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 August 9, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Menthol 10%

    Methyl salicylate 30%

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  • Purpose

    Topical analgesic

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  • Uses

    temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps
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  • Warnings

    For external use only

    SEE INSIDE LABEL FOR COMPLETE DRUG FACTS

    Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    adults and children over 12 years:

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but not more than 4 times daily

    children 12 years or younger: ask a doctor

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  • Inactive ingredients

    ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111)

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    COLD AND HEAT PAIN RELIEVING CREAM 
    menthol and methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:72351-010
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 30 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72351-010-00 208 g in 1 BOX; Type 0: Not a Combination Product 08/09/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/09/2018
    Labeler - SOTAC PHARMACEUTICALS PRIVATE LIMITED (876894019)
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