Label: COASTAL HAND SANITIZER GEL- hand sanitizer gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79076-900-04, 79076-900-16, 79076-900-25, 79076-900-27, view more79076-900-32, 79076-900-41 - Packager: U.S. BEVERAGE, 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 August 4, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
Coasstal Hand Sanitizer Gel hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade active ingredient in the preparation of the product (percentage in final product formulation)
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20
Inactive Ingredients
- Glycerol (7.6% v/v).
- Isopropyl Alcohol ((0.3% v/v)
- Hydrogen peroxide (0.1% v/v).
- Carbomer (0.4%)
- Vitamin E (0.3% v/v)
- Sterile distilled water
Label Gallon Bottle with FDA Logo 1 gallon
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
COASTAL HAND SANITIZER GEL
hand sanitizer gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79076-900 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 2649.5 mL in 3785 mL Inactive Ingredients Ingredient Name Strength CARBOMER 940 (UNII: 4Q93RCW27E) 151.4 mL in 3785 mL ISOPROPYL ALCOHOL (UNII: ND2M416302) 113.55 mL in 3785 mL ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 11.355 mL in 3785 mL GLYCERIN (UNII: PDC6A3C0OX) 287.66 mL in 3785 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 37.85 mL in 3785 mL WATER (UNII: 059QF0KO0R) 533.685 mL in 3785 mL Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79076-900-41 00 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 2 NDC:79076-900-32 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 3 NDC:79076-900-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 4 NDC:79076-900-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 5 NDC:79076-900-25 9463 mL in 1 BAG; Type 0: Not a Combination Product 07/01/2020 6 NDC:79076-900-27 1040988 mL in 1 CONTAINER; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/26/2020 Labeler - U.S. BEVERAGE, INC. (180035917) Establishment Name Address ID/FEI Business Operations U.S. BEVERAGE, INC. 180035917 manufacture(79076-900)