Label: FREEZE COOLING PAIN RELIEF gel

  • 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 January 25, 2021

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  • Active Ingredient(s)

    Menthol 4%

  • Purpose

    /

  • Use

    Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.

  • Warnings

    for external use only.
    In cose of Ingestion seek medical assistance.
    If a rash appears, dis.continue use.

  • Do not use

    If you are allerglc to any of the ingredients, on inflamed or broken skin around the eyes with other topical treatments under bandages or occlusive dressings on children under the age of 12

  • WHEN USING

    If you are allerglc to any of the ingredients, on inflamed or broken skin around the eyes with other topical treatments under bandages or occlusive dressings on children under the age of 12

  • STOP USE

    Consult your doctor or pharmacist before use if you are diabetic, pregnant or breastfeeding. have poor circulation, a skin condition or if symptoms persists.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.

  • Other information

  • Inactive ingredients

    Water, Alcohol Denat., Polysorbate-20, Glycerin, Propylene Glycol, Triethanolamine, Phenoxyethanol, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer. Cinnamomum Camphora (Camphor) bark oil, Ethylhexylglycerin, limonene, Linalool, Cl42090 (FD&C Blue 1), CL17200 (D&C Red 33).

  • Package Label - Principal Display Panel

    69980-102-05 200ml

    69980-102-05 200ml

    69980-102-04 150ml69980-102-04 150ml

    69980-102-02 50ml

    69980-102-02 50ml

    69980-102-01 30ml 69980-102-01 30ml

    69980-102-03 100ml 69980-102-03 100ml

    69980-102-06 30ml

    69980-102-06 30ml

    69980-102-07 50ml

    69980-102-07 50ml

    69980-102-08 100ml

    69980-102-08 100ml

    69980-102-09 150ml

    69980-102-09 150ml

    69980-102-010 200ml

    69980-102-010 200ml

    69980-102-011 227ml

    69980-102-011 227ml

  • INGREDIENTS AND APPEARANCE
    FREEZE COOLING PAIN RELIEF 
    freeze cooling pain relief gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69980-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69980-102-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:69980-102-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:69980-102-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:69980-102-04150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:69980-102-05200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    6NDC:69980-102-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    7NDC:69980-102-0750 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    8NDC:69980-102-08100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    9NDC:69980-102-09150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    10NDC:69980-102-10200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    11NDC:69980-102-11227 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/30/2020
    Labeler - Shandong Vianor Healthy Science Co.,Ltd. (554532204)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Vianor Healthy Science Co.,Ltd.554532204manufacture(69980-102)
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