Hand Sanitizer: Package Insert and Label Information

HAND SANITIZER- alcohol gel
Shanghai Zuwei Medical Healthcare Instruments 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.

Active Ingredients

Active Ingredients
Alcohol 75%

Purpose

Purpose
Antiseptic

Use

Use Helps reduce bacteria that potentially can cause disease.

Warnings

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

Do not use

Do not use

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

When using this product

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

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children

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

Directions

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

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Inactive ingredients Aloe Vera extract, Carbomer, Glycerol, Triethanolamine, Vitamin E, Water(Purified)

Package Label — Principal Display Panel

100 ml NDC: 77204-001-01

Front & Back Label for 100 ml Hand Sanitizer
(click image for full-size original)
HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77204-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.15 mL in 100 mL
TRIETHANOLAMINE DODECYLBENZENESULFONATE 0.35 mL in 100 mL
WATER 24 mL in 100 mL
TOCOPHEROL 0.1 mL in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE 0.3 mL in 100 mL
ALOE VERA LEAF 0.1 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77204-001-01 100 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/06/2020
Labeler — Shanghai Zuwei Medical Healthcare Instruments Co.,Ltd. (554532468)

Revised: 07/2020 Shanghai Zuwei Medical Healthcare Instruments Co.,Ltd.

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