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
  • 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 August 30, 2023

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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 not finalpart34809/30/2023
    Labeler - FAMILY DOLLAR (Family Wellness) (024472631)
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