Label: FAMILY WELLNESS HOT AND COLD PAIN RELIEF- hot and cold pain relief cream

  • NDC Code(s): 55319-824-35
  • Packager: FAMILY DOLLAR (Family Wellness)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2024

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  • Drug Facts 

  • Active ingredients 

    Menthol - 10%

    Methyl salicylate -30%

  • Purpose

    Topical Analgesic

    Topical Analgesic

  • Uses

    For temporary relief of minor aches and pains of muscle and joints associated with;

    • simple backaches, arthritis, strains, bruises and sprains
  • Warning

    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 condiitions

    Ask a doctor before use if you have; redness over thre affected area

  • When using this product 

    • avoid contact with eyes and 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 occur
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Use only as directed

    Adults and children 2 years of age and older;

    • Apply to affected area not more than 3 to 4 times daily.

    Children under 2 years of age; ask a doctor.

  • Other information 

    Store at controlled room temperature 20°- 25°C ( 68° to 77°F)

  • Inactive ingredients 

  • Questions? 1-800 814-8028

  • Principal Display Panel -Tube

    Family Wellness          NDC 55319-824-35

    Cold & Hot Pain Relief Cream 

    MENTHOL 10%

    METHYL SALICYLATE 30%

    NET WT 1.25 OZ (35.4g)

    FD_ColdHot PainRelief_Tube

  • Principal Display Panel -Carton 

    Family Wellness       NDC 55319-824-35

    Cold & Hot Pain Relief Cream

    MENTHOL 10%

    METHYL SALICYLATE 30%

    NET WT 1.25 OZ (35.4g)

    FD_ColdHotPainRelief_Carton

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS HOT AND COLD PAIN RELIEF 
    hot and cold pain relief cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-824
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    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:55319-824-351 in 1 CARTON09/30/2023
    135.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/30/2023
    Labeler - FAMILY DOLLAR (Family Wellness) (024472631)
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