UNISHIELD HAND SANITIZER- ethyl alcohol gel

Unishield Hand Sanitizer by

Drug Labeling and Warnings

Unishield Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Unishield, Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Ethyl Alcohol, 75% v/v

PURPOSE

Purpose  Antiseptic

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only.

Flammable, keep away from heat or flame.

Do not use

• In children less than two 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 throughly with water

Stop use and ask a doctor if irritation or rash occurs. They may be signs of a serious condition.

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.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

acrylates/ C10-C30 alkyl acrylate crossploymer, aminomethyl propanol, aloe barbadensis leaf jiuce,denatonium benzoate,fragrance, glycerin,maltodextrin, propylene glycol, tocopheryl acetate, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNISHIELD HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49314-0004-1	25 in 1 BOX	11/15/2023
1		0.9 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	11/15/2023

Labeler - Unishield (790677053)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(49314-0004)