EGOLAN- ethyl alcohol gel

EGOLAN by

Drug Labeling and Warnings

EGOLAN by is a Otc medication manufactured, distributed, or labeled by Sanrace Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use[s]

Hand sanitizer to help reduce bacteria 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 15-30°C (59-83°F)
• Avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Propylene glycol, Carbomer, Aloe yohjyu matsu ekisu, Triethanolamine, Disodium Edta

SPL UNCLASSIFIED SECTION

Alcohol

*99.99% of most common germs.

Manufacturer:

Sanrace Biotechnology Co., Ltd

Manufacturer Address:268 Yanzhou Road,

Lanxi Development Zone, Zhejiang Province.

Made In China

Packaging

INGREDIENTS AND APPEARANCE

EGOLAN 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75448-022
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75448-022-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2020
2	NDC: 75448-022-11	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2020
3	NDC: 75448-022-12	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2020
4	NDC: 75448-022-13	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2020
5	NDC: 75448-022-14	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2020
6	NDC: 75448-022-15	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2020
7	NDC: 75448-022-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/29/2020

Labeler - Sanrace Biotechnology Co., Ltd. (543000938)

Establishment
Name	Address	ID/FEI	Business Operations
Sanrace Biotechnology Co., Ltd.		543000938	manufacture(75448-022)