Label: ALCOHOL FREE FOAMING HAND SANITIZER- benzalkonium chloride soap
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NDC Code(s):
65601-700-03,
65601-700-04,
65601-700-05,
65601-700-29, view more65601-700-53, 65601-700-55, 65601-700-57, 65601-700-88
- Packager: Betco Corporation, Ltd.
- 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 11, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Alcohol Free Foaming Hand Sanitizer
- Alcohol Free Foaming Hand Sanitizer
-
Alcohol Free Foaming Hand Sanitizer
Warnings
- For external use only.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Discontinue use is irritation or redness develops.
- If irritation persists for more than 72 hours, consult a physician.
- KEEP OUT OF REACH OF CHILDREN.
- If swallowed, get medical help or contact a Poison Control Center right away.
- Alcohol Free Foaming Hand Sanitizer
- Alcohol Free Foaming Hand Sanitizer
- Alcohol Free Foaming Hand Sanitizer
- Alcohol Free Foaming Hand Sanitizer
- Alcohol Free Foaming Hand Sanitizer
- Alcohol Free Foaming Hand Sanitizer
-
INGREDIENTS AND APPEARANCE
ALCOHOL FREE FOAMING HAND SANITIZER
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65601-700 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength GRAPEFRUIT OIL (UNII: YR377U58W9) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) MAGNESIUM NITRATE (UNII: 77CBG3UN78) .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) CYCLOMETHICONE 4 (UNII: CZ227117JE) ACETALDEHYDE (UNII: GO1N1ZPR3B) GERANIOL (UNII: L837108USY) HEXAMETHYLINDANOPYRAN (UNII: 14170060AT) DIHYDROMYRCENOL (UNII: 46L1B02ND9) METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) MYRCENE (UNII: 3M39CZS25B) SODIUM PIDOLATE (UNII: 1V74VH163T) ISOPROPYL ALCOHOL (UNII: ND2M416302) N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS) LINALOOL, (+/-)- (UNII: D81QY6I88E) ORANGE OIL (UNII: AKN3KSD11B) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) PEG/PPG-15/15 ALLYL ETHER ACETATE (UNII: 8RP39FN7AJ) HEXYL SALICYLATE (UNII: 8F78EY72YL) ALCOHOL (UNII: 3K9958V90M) LIME OIL (UNII: UZH29XGA8G) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) WATER (UNII: 059QF0KO0R) DIOXANE (UNII: J8A3S10O7S) PEG-6 COCAMIDE (UNII: YZ6NLA4O1E) LEMON OIL (UNII: I9GRO824LL) Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65601-700-53 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2016 2 NDC:65601-700-29 1000 mL in 1 BAG; Type 0: Not a Combination Product 01/01/2016 3 NDC:65601-700-04 3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2016 4 NDC:65601-700-57 550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2016 09/11/2020 5 NDC:65601-700-55 207900 mL in 1 DRUM; Type 0: Not a Combination Product 01/01/2016 6 NDC:65601-700-03 750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/15/2016 07/15/2020 7 NDC:65601-700-05 1250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/15/2016 09/11/2020 8 NDC:65601-700-88 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/12/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/12/2012 Labeler - Betco Corporation, Ltd. (024492831) Registrant - Betco corporation, Ltd. (024492831) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd. 024492831 manufacture(65601-700) , pack(65601-700) , label(65601-700)