M MARVEL SANI CARE Instant Hand Sanitizer: Package Insert and Label Information

M MARVEL SANI CARE INSTANT HAND SANITIZER- alcohol gel
GUANGZHOU TECHIN DEVELOPMENT 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.

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

For daily hand sanitizing, to reduce bateria on hands

Warnings

For external use only

Flammable. Keep away from fires and high temperature

Do not use on open skin wounds

Avoid eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use if irritation or rash occurs, if condition persists, contact a healthcare proactitioner

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Put proper amount onto palms and rub hands briskly until dry.
• No washing or rinsing required. Air dries quickly

Other information

Keep in closed container in a cool dry place of ambient temperature between 5-30C (59-86F)

Batch and MFG date printed on bottle

Validity: 24 mounths from MFG date

Made in China

Inactive ingredients

Water, Aminomethyl propanol, aloe vera extract, glycerin, carbomer, D-Panthenol, vitamin E

M MARVEL SANI CARE INSTANT HAND SANITIZER alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80107-001 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 WATER CARBOMER 940 GLYCERIN ALOE VERA WHOLE .ALPHA.-TOCOPHEROL ACETATE AMINOMETHYLPROPANOL PANTHENOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:80107-001-01 30 mL in 1 BOTTLE None 2 NDC:80107-001-02 60 mL in 1 BOTTLE None 3 NDC:80107-001-03 250 mL in 1 BOTTLE None 4 NDC:80107-001-04 500 mL in 1 BOTTLE None 5 NDC:80107-001-05 1000 mL in 1 BOTTLE None 6 NDC:80107-001-06 3785 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/26/2020

Labeler — GUANGZHOU TECHIN DEVELOPMENT CO., LTD (527219392)

Establishment
Name	Address	ID/FEI	Operations
GUANGZHOU TECHIN DEVELOPMENT CO., LTD		527219392	manufacture (80107-001)

Revised: 08/2020 GUANGZHOU TECHIN DEVELOPMENT CO., LTD