HAND SANITIZER- ethanol gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by BOTANICALS INTERNACIONAL S.A. DE C.V, BOTANICALS INTERNACIONAL S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients.................Purpose
Ethyl Alcohol 70%...................Antiseptic

900ML NDC: 51384-002-01

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

900ML NDC: 51384-002-01

Use: hands sanitizer to help decrease bacteria on the skin.

900ml NDC: 51384-002-01

Warnings Flammable. Keep away from fire or flame. For external use only. When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.

900ml NDC: 51384-002-01

Direction: Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years old should be supervised when using this product.

900ml NDC: 51384-002-01

Usage Direction: Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years old should be supervised when using this product.

900ml NDC: 51384-002-01

Inactive ingredients: water 28%, glycerin 1%, carbopol 940 0.50%,TEA 85 0.50%,

900ML NDC: 51384-002-01

Warnings Flammable. Keep away from fire or flame. For external use only.

900ML NDC: 51384-002-01

FRONT DISPLAY

900ML NDC: 51384-002-01

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51384-002
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
WATER (UNII: 059QF0KO0R)	28 mL  in 100 mL
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)	0.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51384-002-01	900 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/13/2020

Labeler - BOTANICALS INTERNACIONAL S.A. DE C.V (823968961)

Registrant - BOTANICALS INTERNACIONAL S.A. DE C.V. (823968961)

Establishment
Name	Address	ID/FEI	Business Operations
BOTANICALS INTERNACIONAL S.A. DE C.V.		823968961	manufacture(51384-002)