I-SOFTTO INSTANT HAND SANITIZER- alcohol gel
Guangdong Essence Daily Chemical 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 Facts

Active ingredient

Ethyl Alcohol 75% (V/V)

Purpose

Antiseptic

Use

To help reduce bacteria on the skin
recomended for repeated use.

Warnings

For external use only.

Flammable,

Keep away from fire or flame or sparks.

When using this product

do not use in or neay eyes, In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears on the skin.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough to cover both hands in the palm, and rub hands together until dry
Children under 6 years of age should be supervised bu an adult when appling this products.

Inactive ingredients

aloe barbadensis leaf juice, carbomer, Glycerin, Triethanolamine, water

Other information

Do not store above 105 Fahrenheit.
May discolor certain fabrics or surfaces.
Harmful to wood finishes and plastics.

Packaging

image description

I-SOFTTO INSTANT HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73931-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINe (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73931-001-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020
2	NDC:73931-001-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/30/2019

Labeler - Guangdong Essence Daily Chemical Co., Ltd (529796211)

Registrant - Guangdong Essence Daily Chemical Co., Ltd (529796211)

Name	Address	ID/FEI	Business Operations
Establishment
Guangdong Essence Daily Chemical Co., Ltd		529796211	manufacture(73931-001)