HAND SANITIZER (RINSE-FREE)- hand sanitizer (rinse-free) gel
Shanghai Rayshine ENVI-TECH Developing 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.

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Hand Sanitizer (Rinse-free)

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

For hand sanitizing to reduce bacteria
on the skin.

Warnings

For extermal use only-hands. Flamable.Keep awaysfrom fire and flame.

When using this product

Keep out of eyes.Do not inhale or ingest. Stop use and ask a doctor if skinimitation develops. Keep out of reach of children.

Directions

Squeez small amount in your palm and briskly rub hands together until dry.

Other information

Inactive ingredients

Water,Carbomer,Triethanolamine,Glycerin,Vitamin E,Aloe Barbadensis.Fragrance.

Package Label - Principal Display Panel

30 ml label 50 ml label 54 ml label 60 ml label 80 ml label 90 ml label 100 ml label 250 ml label 500 ml label 1000 ml label 2000 ml label 3785 ml label 5000 ml label

HAND SANITIZER (RINSE-FREE)
hand sanitizer (rinse-free) gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75129-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75129-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
2	NDC:75129-001-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
3	NDC:75129-001-03	54 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
4	NDC:75129-001-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
5	NDC:75129-001-05	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
6	NDC:75129-001-06	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
7	NDC:75129-001-07	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
8	NDC:75129-001-08	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
9	NDC:75129-001-09	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
10	NDC:75129-001-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
11	NDC:75129-001-11	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
12	NDC:75129-001-12	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
13	NDC:75129-001-13	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/18/2020

Labeler - Shanghai Rayshine ENVI-TECH Developing CO., Ltd. (420836386)

Registrant - Shanghai Rayshine ENVI-TECH Developing CO., Ltd. (420836386)

Name	Address	ID/FEI	Business Operations
Establishment
Shanghai Rayshine ENVI-TECH Developing CO., Ltd.		420836386	manufacture(75129-001)