HAND SANITIZER CDS OFFICE PRODUCTS- alcohol liquid
Jiangxi Sencen Hygienic Products Co., 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.

----------

Drug Fact

Active Ingredient Purpose

Ethyl Alcohol 62% Antibacterial Agent

Purpose: Antibacterial Agent

Uses: For hand cleaning to decrease bacteria on skin

Warnings:

For external use only. If swallowed, seek medical attention. In case of contact with eyes, flush eyes with water and contact a doctor immediately. Discontinue use if skin irritation develops. Keep out of reach of children. Children under 6 years old should be supervised by an adults when using this product.

Keep out of reach of children. Other Information: Store at room temperature

Directions: To decrease bacteria on skin, apply a small amount on palm. Briskly rub, covering hands with product until dry.

Inactive Ingredients: Water Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis, Carbomer, Tocopheryl Acetate, Triethanolamine.

label

HAND SANITIZER CDS OFFICE PRODUCTS
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67772-011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)	0.22 g in 100 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.3 g in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.3 g in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	0.5 g in 100 g
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)	0.1 g in 100 g
TROLAMINE (UNII: 9O3K93S3TK)	0.264 g in 100 g
ALOE VERA FLOWER (UNII: 575DY8C1ER)	0.5 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67772-011-01	1200 g in 1 BAG; Type 0: Not a Combination Product	07/11/2010	07/12/2016
2	NDC:67772-011-02	800 g in 1 BAG; Type 0: Not a Combination Product	07/11/2010	07/12/2016
3	NDC:67772-011-03	400 g in 1 BAG; Type 0: Not a Combination Product	07/11/2010	07/12/2016
4	NDC:67772-011-04	500 g in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2010	07/12/2016
5	NDC:67772-011-05	30 g in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2010	07/12/2016
6	NDC:67772-011-06	300 g in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2010	07/12/2016
7	NDC:67772-011-07	75 g in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2010	07/12/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/08/2010	07/12/2016

Labeler - Jiangxi Sencen Hygienic Products Co., Ltd. (530079318)

Registrant - Jiangxi Sencen Hygienic Products Co., Ltd. (530079318)

Name	Address	ID/FEI	Business Operations
Establishment
Jiangxi Sencen Hygienic Products Co., Ltd.		530079318	manufacture(67772-011)

Revised: 7/2016

Document Id: ae7bf0a8-bb6d-4ed7-a651-eef7eb46e1bd

Set id: 11927c85-b92a-4871-aa2c-0ea66519111f

Version: 2

Effective Time: 20160712

Jiangxi Sencen Hygienic Products Co., Ltd.