Label: RHULI GEL- camphor, menthol gel

  • NDC Code(s): 69396-031-20
  • Packager: Trifecta Pharmaceuticals USA, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 17, 2023

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  • Drug Facts

  • Active Ingredient

    Camphor 0.3%

  • Purpose

    Topical Analgesic

  • Active Ingredient

    Menthol 0.3%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves pain and itching associated with:

    • minor burns
    • scrapes
    • sunburn
    • insect bites
    • minor cuts
    • minor skin irritations
    • rashes due to poison ivy, poison oak, poison sumac
  • Warnings

    For external use only

    Flammable: Keep away from fire or flame

    When using this product: avoid contact with eyes

  • Stop Use and Ask Doctor if:

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again with a few days
  • Keep out of reach of children

    If swallowed, get medical help or contact a 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: ask a doctor
  • Other information:

    • Store at controlled room temperature 20°-25°C (68°-77°F).
    • Close cap tightly after use

    Questions: Call 1-888-296-9067

  • Inactive Ingredients

    • Benzyl alcohol, Carbomer 940, Isopropyl alcohol, Purified water, Trolamine
  • Distributed By:

    Trifecta Pharmaceuticals USA, LLC.

    101 NE Third Ave. Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

  • Packaging

    rhuli gel 2

  • INGREDIENTS AND APPEARANCE
    RHULI GEL 
    camphor, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.3 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-031-201 in 1 BOX05/17/2017
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/17/2017
    Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)
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