Label: RECOVERY ROLL-ON- menthol, camphor gel

  • NDC Code(s): 75249-008-01
  • Packager: SOLITEINT KOZMETIKUM GYARTO ES FORGALMAZO TERMELO ES KERESKEDELMI KORLATOLT FELELOSSEGU TARSASAG
  • 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 February 13, 2023

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  • Active Ingredients

    Menthol 5%

    Camphor 5%

  • Purpose

    Menthol 5%.............Topical Analgesic

    Camphor 5%.............Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    Use only as directed.

    For external use only.

    When using this product:

    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin
    • do not bandage tightly or use with a heating pad, other ointments, creams, sprays, or liniments.

    Stop use and ask doctor if:

    • condition worsens
    • symptoms persist for more than 7 days, or clear up and reoccur again within a few days.

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.

  • Directions

    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:

    • Consult a doctor.
  • Other Information

    • Store in a cool, dry place.
    • Avoid direct sunlight.
    • Tamper-evident for your protection. Use only if safety seal is intact.
    • Keep away from excessive heat or flame.
  • Inactive Ingredients

    Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Dimethyl Sulfone, Magnesium Chloride, Cetearyl Alcohol, Glyceryl Stearate, Polyglyceryl-6 Palmitate/Succinate, Glycerin, Hydroxyacetophenone, Tocopheryl Acetate, Xanthan Gum, Caprylyl Glycol, 1,2-Hexanediol, Acacia Senegal Gum, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Magnesium Sulfate, Potassium Chloride, Sodium Chloride, Calcium Chloride

  • Questions or Comments?

    888-819-6472; Monday-Friday, 9am-5pm CT; Report any serious side effects to number above.

  • PRINCIPAL DISPLAY PANEL

    NDC: 72683-008-01

    Non-toxic

    Paraben Free

    Asutra*

    Recovery Roll-On

    5% Menthol + 5% Camphor

    Pain Relief Gel

    With Revitalizing Magnesium

    1.7 fl. oz. | 50 ml.

    1

    2

  • INGREDIENTS AND APPEARANCE
    RECOVERY ROLL-ON 
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75249-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)5 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ACACIA (UNII: 5C5403N26O)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75249-008-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/17/2022
    Labeler - SOLITEINT KOZMETIKUM GYARTO ES FORGALMAZO TERMELO ES KERESKEDELMI KORLATOLT FELELOSSEGU TARSASAG (401476254)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag401476254manufacture(75249-008)
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