Hand Sanitizer by GUANGDONG HAOSHUN ODIS TECHNOLOGY COMPANY LIMITED HAND SANITIZER gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by GUANGDONG HAOSHUN ODIS TECHNOLOGY COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Information -

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations.

Active ingredient & Purpose

Antiseptic, Hand Sanitizer

• Active ingredient: Purpose
• Alcohol 75% v/v....................: Antiseptic

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.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

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

Inactive ingredients

glycerin, trolamine, betaine, carbomer homopolymer, purified water USP

Packaging Label

1.9L ml NDC: 74895-103-09

473 ml NDC: 74895-103-08

295 ml NDC: 74895-103-07

59 ml NDC: 74895-103-06

80 mL NDC: 74895-103-01

480 mL NDC: 74895-103-02

290 mL NDC: 74895-103-03

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74895-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.35 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.12 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL  in 100 mL
BETAINE (UNII: 3SCV180C9W)	0.25 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74895-103-01	80 mL in 1 TUBE; Type 0: Not a Combination Product	06/05/2020
2	NDC: 74895-103-02	480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/05/2020
3	NDC: 74895-103-03	290 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/05/2020
4	NDC: 74895-103-04	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/05/2020
5	NDC: 74895-103-05	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/05/2020
6	NDC: 74895-103-06	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/05/2020
7	NDC: 74895-103-07	295 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/05/2020
8	NDC: 74895-103-08	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/05/2020
9	NDC: 74895-103-09	1900 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/05/2020

Labeler - GUANGDONG HAOSHUN ODIS TECHNOLOGY COMPANY LIMITED (547109432)