INSTANT HAND SANITISER gel

INSTANT HAND SANITISER by

Drug Labeling and Warnings

INSTANT HAND SANITISER by is a Otc medication manufactured, distributed, or labeled by JinHua Denise Cosmetics CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antisepic

Use

To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.

Warnings

For external use only hands. Fammable. Keep away from fire or flame.When using this product Keep out of eyes, ears, or mouth. In case of eye
contact, fiush eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.
Stop use and ask a doctor if rednes or irritation develop. condition persists for more than 72 hours.
Keep out of reach of children
Children should be supervised by an adult when using this product. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

Do not inhale or ingest

WHEN USING

When using this product Keep out of eyes, ears, or mouth. In case of eye
contact, fiush eyes thoroughly with water. Avoid contact with broken skin.

STOP USE

Stop use and ask a doctor if rednes or irritation develop. condition persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children
Children should be supervised by an adult when using this product. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping. No rinsing required, For children under 6, use only under adult supervision. Not recommended for infants.

Other information

Store below 105°F (40 °C). May discolor certain fabrics. Harmful to wood finishes & plastics

Inactive ingredients

Water(Aqua), Triethanolamine, Carbomer, Aloe
Barbadensis Leaf Extract, Fragrance, Glycerin, Propylene Glycol,Tocopheryl Acetate (Vitamin E).

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITISER 
instant hand sanitiser gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77663-006
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
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77663-006-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 77663-006-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 77663-006-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - JinHua Denise Cosmetics CO., LTD. (554532652)

Establishment
Name	Address	ID/FEI	Business Operations
JinHua Denise Cosmetics CO., LTD.		554532652	manufacture(77663-006)