SUDESAN HAND SANITIZER ORIGINAL- alcohol solution
Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch

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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Active Ingredient(s)

Ethyl Alcohol 62%

Purpose

Antiseptic

Use

Hand sanitizer to help decrease bacterial on the skin

When water, soap and towel are not available

Recommended for repeated use

Warnings

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

Do not apply around eyes.

Do not use in ears and mouth.

When using this product, avoid contact with eyes. In case of contact, flush eyes with water

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours

Keep out of reach of children. Children must be supervised in use of this products.

Directions

Pump as needed into your palms and thoroughly spread on both hands

Rub into skin until dry.

Other information

Store at 20C (68 to 77F)

May discolor fabrics

Inactive ingredients

Water, carbomer, triethanolamine, glycerol, aloe barbadensis leaf juice

image description

SUDESAN HAND SANITIZER ORIGINAL
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75112-002
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
GLYCEROL FORMAL (UNII: 3L7GR2604E)
CARBOMER 934 (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75112-002-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2020
2	NDC:75112-002-02	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2020
3	NDC:75112-002-03	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2020
4	NDC:75112-002-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2020
5	NDC:75112-002-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2020
6	NDC:75112-002-06	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2020
7	NDC:75112-002-07	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2020
8	NDC:75112-002-08	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/10/2020

Labeler - Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch (414137820)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch		414137820	manufacture(75112-002)