Label: SIGNATURE CARE COLD AND HOT- menthol, and 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 15, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Methol 10%........................................... Topical analgesic

    Methyl Salicylate 30%........................... Topical analgesic

  • PURPOSE

    Uses

    • temporarily relieves minor pain associated with:
    • muscle sprains
    • muscle strains
    • simple backache
    • bruises
    • arthritis
    • cramps
  • WARNINGS

    Warnings

    For external use only

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

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
  • WHEN USING

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly
  • STOP USE

    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
    • redness of the skin is present
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • use only as directed
    • adults and children 12 years of age and older:
    • 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 under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    carbomer, cetostearyl alcohol, cetyl esters, polysorbate 60, purified water, steareth-20, stearic acid, trolamine

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Better Living Brands LLC

    Made in China

  • PRINCIPAL DISPLAY PANEL

    79861

  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE COLD AND HOT 
    menthol, and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-861
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-861-361 in 1 CARTON01/20/2021
    136 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 finalpart34801/20/2021
    Labeler - Safeway Inc. (009137209)