Label: ICE BLUE PAIN ALLEVIATING RUB (menthol, unspecified form, methyl salicylate, camphor- natural gel
ICE BLUE PAIN ALLEVIATING RUB (menthol, unspecified form, methyl salicylate, camphor- natural spray

  • 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 31, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Methyl Salicylate8%

    Menthol 5.0%

    Camphor 3.0%

  • Purpose

    Topical analgesic

    Topical analgesic

    Topical analgesic

  • INDICATIONS & USAGE

    Uses provides temporary relief of minor aches and pains in muscles and joints associated with

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

    For external use only

    When using this product use only as directed

    • do not bandage or apply heating pads
    • do not apply to wounds or damaged skin
    • avoid contact with eyes and mucous membranes

    Stop use and ask a doctor if

    • condition worsens
    • irritation develops
    • symptoms persist for more than 8 days or clear up and return

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

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control immediately.

  • Directions

    Adults and children over 12 years:

    Apply generously to affected area

    Massage until gel is completely absorbed by skin. Repeat as necessary

    Children under 12 years: ask a doctor before use

  • Inactive Ingredients

    DMDM Hydantoin, Eucalyptus Globulus Leaf Oil, FD&C Blue No 1, Glycerin, Isopropyl Alcohol, PEG-40 Hydrogenated Castor Oil, Purified Water.

  • Principal Display Panel – 8 oz Spray Label

    Greaseless

    SIN GRASA

    Rx
    Rysell®

    ICE
    BLUE®
    FORTE

    • PAIN ALLEVIATING RUB
    • ALIVIO RÁPIDO DEL DOLOR

    Analgesic/ Analgésico

    SPRAY

    Net Wt. 4 Oz. (118.2 g)e

    Principal Display Panel – 8 oz Spray Label
  • Principal Display Panel – 8 oz Gel Label

    Greaseless

    SIN GRASA

    Rx
    Rysell®

    ICE
    BLUE®

    Analgesic/ Analgésico

    Gel

    • PAIN ALLEVIATING RUB
    • ALIVIO RÁPIDO DEL DOLOR

    Net Wt. 8 Oz. (226.7 g)e

    Principal Display Panel – 8 oz Gel Label
  • INGREDIENTS AND APPEARANCE
    ICE BLUE PAIN ALLEVIATING RUB 
    menthol, unspecified form, methyl salicylate, camphor (natural) gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82988-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.025 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.022 g  in 1 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.003 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82988-101-08226.7 g in 1 JAR; Type 0: Not a Combination Product08/31/2022
    2NDC:82988-101-16453.5 g in 1 JAR; Type 0: Not a Combination Product08/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/31/2022
    ICE BLUE PAIN ALLEVIATING RUB 
    menthol, unspecified form, methyl salicylate, camphor (natural) spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82988-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.05 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.08 g  in 1 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Glycerin (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82988-102-04118.2 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/31/2022
    Labeler - Lemisol Corporation (040708586)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetics & Cleaners International, LLC. DBA C&C Industries018949897MANUFACTURE(82988-101, 82988-102)
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