Label: FUNDAMENTALS HANDLOTION- 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 December 26, 2020

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  • SPL UNCLASSIFIED SECTION

    The hand lotion is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

    Benzalkonium chloride

    Water (aqua)
    Glycerin
    C12-15 Alkyl benzoate
    propylene glycol
    stearyl alcohol
    cetyl alcohol
    Petrolatum
    Lavendar oil
    aloe barbadensis (aloe vera) leaf juice
    retinyl palmitate (vitamin A)
    tocopheryl acetate (vitamin E)
    dimethicone
    sodium acrylate
    acryloyldimethyltaurate copolymer
    polysorbate 80
    isohexadecane
    polysorbate 60
    acrylates/C10 30 Alkyl acrylate crosspolymer
    hexylene glycol
    xanthan gum
    sodium hydroxide
    phenoxyethanol
    caprylyl glycol
    ethylhexylglycerin
    fragrance (parfum)

  • Active Ingredient(s)

    Benzalkonium chloride 0.13% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial

  • Use

    To decrease bacteria on skin

    Recommended for repeat use

  • Warnings

    For external use only.

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if

    irritation or redness develop

    Condition persists more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Dispense lotion onto hands and rub into skin until absorbed

    Supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • Store between 15-30°C (59-86°F) .
      • Avoid freezing and excessive heat above 40°C (104°F).
  • Inactive ingredients

    Water (aqua)

    Glycerin

    C12-15 Alkyl benzoate

    propylene glycol

    stearyl alcohol

    cetyl alcohol

    Petrolatum

    Lavendar oil

    aloe barbadensis (aloe vera) leaf juice

    retinyl palmitate (vitamin A)

    tocopheryl acetate (vitamin E)

    dimethicone

    sodium acrylate

    acryloyldimethyltaurate copolymer

    polysorbate 80

    isohexadecane

    polysorbate 60

    acrylates/C10 30 Alkyl acrylate crosspolymer

    hexylene glycol

    xanthan gum

    sodium hydroxide

    phenoxyethanol

    caprylyl glycol

    ethylhexylglycerin

    fragrance (parfum)

  • Do not Use

    Do not Use

    in children less than 2 months old

    on open skin wounds

  • Package Label - Principal Display Panel

    236 mL NDC: 76665-022-08

    8oz

    60 mL NDC: 76665-022-02

    2oz

    473 ml NDC: 76665-022-16

    16oz

    3785 ml NDC: 76665-022-01

    1 Gal

  • INGREDIENTS AND APPEARANCE
    FUNDAMENTALS HANDLOTION 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76665-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.1 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.12 mL  in 100 mL
    FRAGRANCE LAVENDER ORC1800979 (UNII: 1B40MIN2W5) 0.1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 78.273 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 3.15 mL  in 100 mL
    PETROLATUM (UNII: 4T6H12BN9U) 1.9 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 4.85 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.15 mL  in 100 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) 0.34 mL  in 100 mL
    SODIUM ACRYLATE (UNII: 7C98FKB43H) 0.14 mL  in 100 mL
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) 0.145 mL  in 100 mL
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.85 mL  in 100 mL
    HEXYLENE GLYCOL (UNII: KEH0A3F75J) 0.14 mL  in 100 mL
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 2.145 mL  in 100 mL
    CETYL ALCOHOL (UNII: 936JST6JCN) 1.852 mL  in 100 mL
    LAVENDER OIL (UNII: ZBP1YXW0H8) 0.125 mL  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 mL  in 100 mL
    ISOHEXADECANE (UNII: 918X1OUF1E) 0.47 mL  in 100 mL
    POLYSORBATE 60 (UNII: CAL22UVI4M) 0.74 mL  in 100 mL
    CARBOMER 1342 (UNII: 809Y72KV36) 0.2 mL  in 100 mL
    XANTHAN GUM (UNII: TTV12P4NEE) 0.15 mL  in 100 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.05 mL  in 100 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.2 mL  in 100 mL
    C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C) 3.44 mL  in 100 mL
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.14 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76665-022-08236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/01/2020
    2NDC:76665-022-013785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/01/2020
    3NDC:76665-022-0260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/01/2020
    4NDC:76665-022-16473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2020
    Labeler - Clean Beauty Concepts (117491649)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clean Beauty Concepts117491649manufacture(76665-022)
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