Label: 4RLF TOPICAL ANALGESIC- menthol cream

  • Category: HUMAN OTC DRUG LABEL

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 October 28, 2022

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  • ACTIVE INGREDIENTS

    Menthol 0.10%

  • PURPOSE

    TOPICAL ANALGESIC

  • USES

    For the temporary relief of pain from minor burns, sunburn, minor cuts, scrapes, and insect bites.

  • WARNINGS

    For external use only. When using this product ■ Avoid contact with eyes. In case of eye contact, flush eyes with water. ■ If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

  • ■ Keep out of reach of children.

     If swallowed, get medical help.

  • DIRECTIONS FOR USE

    ■ Adults and children 2 years of age or older:
    Apply to the desired area and gently rub into the skin, not more than
    3 to 4 times daily. ■ Children under the age of 2: Consult a physician.

  • INACTIVE INGREDIENTS

    Propylene Glycol, Ocimum Tenuiflorum Callus Culture Lysate, Glycerin, Dimethyl Sulfone, Water, Withania Somnifera Root Extract, Piper Nigrum (Pepper) Fruit Extract, Gluconolactone, Sodium Benzoate, Citric Acid, Xanthan Gum, Citrus Aurantium Dulcis (Orange) Oil, Hydroxyethylcellulose.

  • OTHER INFORMATION

    ■ Storage Instructions: Store in a cool, dark place (<100°F). Avoid storage directly in sunlight.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Rinati_4RLF_1mL.jpg

  • INGREDIENTS AND APPEARANCE
    4RLF TOPICAL ANALGESIC 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76849-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    OCIMUM TENUIFLORUM WHOLE (UNII: 7OS52KZ33J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    WATER (UNII: 059QF0KO0R)  
    WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
    PIPER NIGRUM WHOLE (UNII: 49L10LI8DN)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76849-201-111 in 1 CARTON08/23/2021
    110 in 1 BLISTER PACK
    11 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/23/2021
    Labeler - Rinati Skin, LLC (109530208)
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