HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Design Element Group INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 75%

ASK DOCTOR/PHARMACIST

Stop use and ask a doctor if irritation or redness develops & condition persists for more than 72 hours.

DO NOT USE

Do no apply around eyes.

When using this product avoid contact with eyes. In case of contact flush eyes with water.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Children must be supervised in use of this product.

PURPOSE

Helps decrease bacteria on skin.

Recommended for repeated use.

STOP USE

Stop use and ask a doctor if irriation or redness develops & condition persists for more than 72 hours.

WHEN USING

When using this product avoid contact with eyes. In case of contact flush eyes with water.

OTHER SAFETY INFORMATION

Store at 20 C( 68-77 F)

May discolor fabrics

STORAGE AND HANDLING

Store at 20 C (68-77F)

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzophenone-4, Fragrance Glycerin, Tocopheryl Acetate

WARNINGS

For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes.

INSTRUCTIONS FOR USE

Pump as needed into your palms & thoroughly spread on both hands.

DOSAGE & ADMINISTRATION

Active 75% ethyl alcohol

INDICATIONS & USAGE

Help decrease bacteria on skin.

Pump as needed into your palms & thoroughly spread on both hands.

hand sanitizer gel

75% active ethyl alcohol

inactive ingredients

acrylate crosspolymer

benzophenone-4

fragrance glycerin

tocopheryl acetate

PRINCIPAL DISPLAY PANEL

75% Alcohol

Hand sanitizer with added moisturiser

Feeling clean and smooth

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81011-128
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)
FRAGRANCE FRESHWATER CUCUMBER ORC2000871 (UNII: NL1QX9C6TG)
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81011-128-01	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/05/2020
2	NDC: 81011-128-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/05/2020
3	NDC: 81011-128-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/05/2020
4	NDC: 81011-128-04	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/05/2020
5	NDC: 81011-128-05	1000 mL in 1 POUCH; Type 0: Not a Combination Product	11/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/02/2020

Labeler - Design Element Group INC (023273678)

Registrant - Design Element Group INC (023273678)

Establishment
Name	Address	ID/FEI	Business Operations
Design Element Group INC		023273678	manufacture(81011-128)