Label: GELLE-N-DETOX - LAVENDER AND ROSEMARY MASSAGE- benzalkonium chloride lotion

  • 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 September 21, 2023

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Antimicrobial

  • USES:

    To decrease bacteria on the skin.

  • WARNINGS

    For external use only.

    Do not use on wounds or damaged skin, with a heating pad or on a child under 12 years of age.

  • WHEN USING

    Avoid contact with the eyes.

    Do not apply to the irritated skin or if excessive irritation develops.

  • ASK DOCTOR

    Ask a doctor before use if you have redness over affected area.

  • PREGNANCY 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:

    Apply a full-palm amount or as needed to cover the affected area (hands, feet, body). Rub until absorbed.

  • OTHER SAFETY INFORMATION

    Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

  • INACTIVE INGREDIENT

    Water (Aqua), Paraffinum Liquidum, Stearic Acid, Cetyl Alcohol, Fragrance (Parfum), Stearyl Alcohol, DMDM Hydantoin, Triethanolamine, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Methylparaben, Propylparaben, Cocos Nucifera Oil (Organic), Argania Spinosa Kernel Oil (Organic), Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Extract, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, D&C Violet No.2 (CI 60730), Benzyl Salicylate, Linalool, Hexyl Cinnamal, Alpha Isomethyl Ionone, Citronellol, Geraniol.

  • QUESTIONS

    Call (305) 623-4445

  • GELLE-N-DETOX LAVENDER & ROSEMARY MASSAGE LOTION 0.7 oz

    ANTIBACTERIAL LOTION LAVENDER

  • INGREDIENTS AND APPEARANCE
    GELLE-N-DETOX - LAVENDER AND ROSEMARY MASSAGE 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49283-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    GERANIOL (UNII: L837108USY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    AMINO ACIDS, WHEAT (UNII: 0370GZL32F)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49283-001-0720 g in 1 POUCH; Type 1: Convenience Kit of Co-Package01/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/18/2023
    Labeler - CHEMCO CORPORATION (032495954)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(49283-001)
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