HAND SANITIZER- alcohol gel
Jiangsu Intco Medical Products 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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Active Ingredient(s)

Alcohol 70% v/v. Purpose:Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Wamings

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

Do not use

On children less than 2 months of age. on open skin wounds.

When using this product do not use in or near the eyes. In case of contact, 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

•Put enough product in your palm to cover hands and rub hands together briskly until dry.

•Children under 6 years of age should be supervised when using this product.

Other information

• Store below 110°F (43°C).

• Avoid freezing and excessive heat above 104°F (40°C).

• May discolor certain fabrics or surfaces.

Inactive ingredients

Aloe Vera, Carbomer lnterpolymer (type B), lemon oil,Glycerin, Triethanolamine, Water (Aqua)

Package label.principal display panel

118ml NDC:74201-846-02 59ml NDC:74201-846-01 473ml NDC:74201-846-03

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74201-846
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEMON OIL (UNII: I9GRO824LL)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74201-846-01	59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/28/2023
2	NDC:74201-846-02	118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/28/2023
3	NDC:74201-846-03	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/28/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/21/2023	09/17/2023

Labeler - Jiangsu Intco Medical Products Co., Ltd (529128686)

Registrant - Jiangsu Intco Medical Products Co., Ltd (529128686)

Name	Address	ID/FEI	Business Operations
Establishment
Jiangsu Intco medical products co., ltd		529128686	manufacture(74201-846)

Revised: 9/2023

Document Id: 0583eced-fbfd-434c-e063-6394a90a323c

Set id: fcff08d0-2277-f421-e053-6294a90aa87a

Version: 4

Effective Time: 20230916

Jiangsu Intco Medical Products Co., Ltd