Label: TOMS RIVER- ethyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 77728-001-01, 77728-001-02 - Packager: Chloris USA 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 May 8, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Keep out of reach of children
- Inactive ingredients
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
TOMS RIVER
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77728-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength LEMON OIL, DISTILLED (UNII: ET5GD00TRP) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) BERGAMOT OIL (UNII: 39W1PKE3JI) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77728-001-01 36 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2020 2 NDC:77728-001-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/08/2020 Labeler - Chloris USA Inc (117517041) Establishment Name Address ID/FEI Business Operations Chloris USA Inc 117517041 manufacture(77728-001)
