INSTANT HAND SANITIZER: Package Insert and Label Information

INSTANT HAND SANITIZER- alcohol gel
Health & Beyond Cosmeceuticals (Chuzhou) 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 Ingredient

Alcohol 75% v/v

Purpose

Antiseptic

Uses

  • 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

  • keep out of eyes, ears, and mouth.
  • In case of contact with eyes, 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

  • 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

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

Inactive Ingredients

Acrylates/C10-30Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Denatonium Benzoate, Fragrance(Parfum), Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water(Aqua).

image of bottle label
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INSTANT HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81766-008
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
MALTODEXTRIN
.ALPHA.-TOCOPHEROL ACETATE
WATER
DENATONIUM BENZOATE
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
ALOE VERA LEAF
AMINOMETHYLPROPANOL
GLYCERIN
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81766-008-01 236 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 04/05/2021
Labeler — Health & Beyond Cosmeceuticals (Chuzhou) Co., Ltd (554544991)

Revised: 04/2021 Health & Beyond Cosmeceuticals (Chuzhou) Co., Ltd

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