CHEMBRITE- hand sanitizer gel 
Interion Pte Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Interion 60% IPA

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

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

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

200 ml NDC: 78036-001-01

CHEMBRITE 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78036-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL60 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78036-001-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
2NDC:78036-001-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
3NDC:78036-001-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
4NDC:78036-001-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
5NDC:78036-001-055000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/25/2020
6NDC:78036-001-0610000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/25/2020
7NDC:78036-001-0720000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/25/2020
8NDC:78036-001-0825000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/25/2020
9NDC:78036-001-0930000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/25/2020
10NDC:78036-001-10200000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/25/2020
11NDC:78036-001-11209000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/25/2020
12NDC:78036-001-121000000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/25/2020
Labeler - Interion Pte Ltd (894599711)
Establishment
NameAddressID/FEIBusiness Operations
Interion Pte Ltd894599711manufacture(78036-001)

Revised: 5/2020
Document Id: a6b26db8-dda7-8449-e053-2995a90a7207
Set id: a6b281df-665d-cc94-e053-2995a90a0da6
Version: 1
Effective Time: 20200528
 
Interion Pte Ltd