OTC Medication Information: Hand Sanitizer

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.

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand sanitizer to help reduce bacteria that 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 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 products.

Other information

• Store below 110°F(43C°)
• Avoid freezing and excessive heat above 40C (104F)
• May discolor certain fabrics or surfaces

Inactive ingredients

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

Package Label — Principal Display Panel

HAND SANITIZER alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74201-268 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN TRIETHANOLAMINE DODECYLBENZENESULFONATE WATER CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) ALOE VERA LEAF LEMON OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:74201-268-02 236 mL in 1 BOTTLE, PUMP None 2 NDC:74201-268-01 118 mL in 1 BOTTLE, PUMP None 3 NDC:74201-268-03 473 mL in 1 BOTTLE, PUMP None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/30/2020

Labeler — Jiangsu Intco Medical Products Co Ltd (529128686)

Establishment
Name	Address	ID/FEI	Operations
Jiangsu Intco Medical Products Co Ltd		529128686	manufacture (74201-268)

Revised: 09/2023 Jiangsu Intco Medical Products Co Ltd