Label: SNO SWEDISH ARCTIC GEL RECOVERY- menthol 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 December 18, 2015

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  • Drug Facts

    Active Ingredients

    Menthol 2.25%

    Purpose

    Topical Analgesic

    Uses

    temporarily relieves minor pain associated with

    • simple backache
    • muscle strains
    • sprains
    • bruises

    Warning

    For external use only

    When using this product use only as directed

    Do not bandage tightly or use with a heating pad

    Avoid contact with eyes or mucous membranes

    Do not apply to wounds or damaged skin.

    Stop use and ask a doctor if

    Condition worsens

    Redness is present

    Irritation develops

    Symptoms persist for more than 7 days or clear up and occur again within a few days

    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 Center right away.

    Directions

    Adults and children over 12 years:

    Apply a thin layer to affected area

    Massage into painful area until thoroughly absorbed into skin

    Repeat as necessary, but no more than 4 times daily

    Children 12 years or younger: ask a doctor

    Other Information

    Store at 68-77°F (20-25°C).

    Protect from excessive moisture.

    Inactive Ingredients

    Arnica montana flower extract

    calendula officinalis extract

    ethylhexylglycerin

    fragrance

    glycerin

    helianthus annuus (sunflower) seed oil

    hydrongenated polydecene

    isostearyl isostearate

    lauryl glucoside

    neoruscogenin

    phenoxyethanol

    propylene glycol

    ruscogenin

    sodium acrylates/beheneth-25 methacrylate crosspolymer

    water

  • Principle Display Panel- 75g tube carton

    sno Swedish Arctic Gel Recovery

  • INGREDIENTS AND APPEARANCE
    SNO SWEDISH ARCTIC GEL RECOVERY 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70316-360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    RUSCOGENIN (UNII: BXI92R2VUJ)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70316-360-021 in 1 CARTON
    175 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 finalpart34812/18/2015
    Labeler - Natumin Pharma AB (426847083)
    Registrant - Natumin Pharma AB (426847083)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natumin Pharma AB426847083manufacture(70316-360)
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