Active Ingredient

Ethyl Alcohol 70% v/v

Keep out of reach of children

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

Antiseptic

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.

Use: hands sanitizer to help decrease bacteria on the skin

Stop use and ask a doctor if irritation or rash appears and lasts.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Inactive ingredients:

water 28%, glycerin 1%, carbopol 940 0.50%,TEA 85 0.50%,

Store below 110 oF (43 oC)

May discolor certain fabrics

NDC: 51384-002-01

Label Label

HAND SANITIZER
ethanol gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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)

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