Label: SANITIZING HAND- benzethonium chloride lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 80994-002-01, 80994-002-02, 80994-002-03, 80994-002-04 - Packager: BELLA BRANDS INC
- 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 November 18, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
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Inactive Ingredients
Water, Ethyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Caprylic/ Capric Triglyceride, Potassium Cetyl Phosphate, Sorbitan Isostearate, Diheptyl Succinate & Capryloyl Glycerin/Sebacic Acid Copolymer, Stearic Acid, Chlorohexidine Gluconate, Carbomer, Polysorbate 20, Aminomethyl Propanol, Tetrasodium EDTA, Camellia Sinensis (Green Tea) Extract1, Glycirrhiza Glabra (Licorice) Root Extract1, Aloe Vera Barbadensis Leaf Juice1, Chamomilla Recutita (Matricaria) Flower Extract1, Phenoxyethanol, Ethylglycerin, Fragrance (Naturally Derived)
- 1
- Organic Ingredient
- Directions For Use
- PRINCIPAL DISPLAY PANEL - 400 ml Bottle Label
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INGREDIENTS AND APPEARANCE
SANITIZING HAND
benzethonium chloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80994-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SUNFLOWER OIL (UNII: 3W1JG795YI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) STEARIC ACID (UNII: 4ELV7Z65AP) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POLYSORBATE 20 (UNII: 7T1F30V5YH) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) EDETATE SODIUM (UNII: MP1J8420LU) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LICORICE (UNII: 61ZBX54883) CHAMOMILE (UNII: FGL3685T2X) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-AMINOBUTYRIC ACID, L- (UNII: 0QAJ5KN9IM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80994-002-01 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2020 2 NDC:80994-002-02 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2020 3 NDC:80994-002-03 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2020 4 NDC:80994-002-04 150 in 1 BOX 05/01/2020 4 1.2 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 05/01/2020 Labeler - BELLA BRANDS INC (034908755) Establishment Name Address ID/FEI Business Operations BELLA BRANDS INC 034908755 MANUFACTURE(80994-002)
