Label: FUNDAMENTALS HANDLOTION- benzalkonium chloride lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76665-020-01, 76665-020-02, 76665-020-08, 76665-020-16 - Packager: Clean Beauty Concepts
- 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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- Official Label (Printer Friendly)
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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
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)
- Purpose
- Use
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
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Inactive ingredients
Water (aqua)
Glycerin
C12-15 Alkyl benzoate
propylene glycol
stearyl alcohol
cetyl alcohol
Petrolatum
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
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
FUNDAMENTALS HANDLOTION
benzalkonium chloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76665-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mg in 100 mL Inactive Ingredients Ingredient Name Strength VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.1 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.12 mL in 100 mL FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.1 mL in 100 mL WATER (UNII: 059QF0KO0R) 78.398 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 .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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76665-020-08 236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/01/2020 2 NDC:76665-020-01 3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/01/2020 3 NDC:76665-020-02 60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/01/2020 4 NDC:76665-020-16 473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/01/2020 Labeler - Clean Beauty Concepts (117491649) Establishment Name Address ID/FEI Business Operations Clean Beauty Concepts 117491649 manufacture(76665-020)