Active Ingredient(s)

Ethyl alcohol (Ethanol)-70 % V/V / Alcool Ethylique 70% V/V

Purpose

Antibacterial (skin) cleanser. Antiseptic (skin) cleanser. Effective in destroying (harmful) bacteria to provide antiseptic cleansing.

Use

For personal hand hygiene to help prevent the spread of bacteria. Kills harmful bacteria/germs. Medicated (skin) cleanser. For use when soap and water are not available.

Warnings

Flammability warning. Keep away from open flame and sources of heat. For external use only.

Do not use

Do not use on children/infants less than 2 years of age (unless directed by a doctor/ physician/ health care practitioner/ health care provider/ health care professional). Do not use on open skin wounds

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation or rash develops.

Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

Directions

Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children when they use this product. For occasional and personal domestic use.

Other information

Store between 15-30C (59-86F), Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water/ Aqua/Eau , Ammonium Acryloyldimethyltaurate, Glycerin, Aloe Barbadensis Leaf Juice, d-alpha-tochopheryl Acetate, fragrance (green tea coriander and mandarin)/ parfum (thé vert coriandre et mandarine).

Package Label - Principal Display Panel

Hand sanitizer gel 1000 ml, NDC: 78064-001-10

Hand sanitizer 3.78 L

78064-001-02

78064-001-01

front label of spary

78064-002-02

back of label spray

DELJINE HAND SANITIZER GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78064-001
Route of Administration	TOPICAL

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
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78064-001-02	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/22/2020
2	NDC:78064-001-10	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/21/2020
3	NDC:78064-001-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/21/2020
4	NDC:78064-001-40	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/21/2020

DELJINE HAND SANITIZER
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78064-002
Route of Administration	TOPICAL

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)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:78064-002-02	236.6 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/22/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/22/2020

Labeler - Deljine Cosmetics corporation (204124143)