Active Ingredient(s)

Isopropyl Alcohol 60% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

in children less than 2 months of age
on open skin wounds

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 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.

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.
Children under 6 years of age should be supervised when using products.

Other information

Store below 110°F(43C°)
Avoid freezing and excessive heat above 40C (104F)

May discolor certain fabrics or surfaces

Inactive ingredients

Benzyl Alcohol, Carboxymethyl Cellulose, Denatonium Benzoate, Glycerin, Lemon peel oil, Monopropylene Glycol, PEG-6000 Dilaurate, Purified Water, Triethanolamine

Package Label - Principal Display Panel

200 ml NDC: 78036-001-01

CHEMBRITE
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78036-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	60 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
PEG-150 DILAURATE (UNII: CF607I8E19)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
LEMON OIL, TERPENELESS (UNII: X69W83NI7V)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78036-001-01	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020
2	NDC:78036-001-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020
3	NDC:78036-001-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020
4	NDC:78036-001-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020
5	NDC:78036-001-05	5000 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/25/2020
6	NDC:78036-001-06	10000 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/25/2020
7	NDC:78036-001-07	20000 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/25/2020
8	NDC:78036-001-08	25000 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/25/2020
9	NDC:78036-001-09	30000 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/25/2020
10	NDC:78036-001-10	200000 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/25/2020
11	NDC:78036-001-11	209000 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/25/2020
12	NDC:78036-001-12	1000000 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/25/2020

Labeler - Interion Pte Ltd (894599711)

Name	Address	ID/FEI	Business Operations
Establishment
Interion Pte Ltd		894599711	manufacture(78036-001)

Interion 60% IPA