HEALTH SMART INSTANT HAND SANITIZER- alcohol solution

Health Smart Instant Hand Sanitizer by

Drug Labeling and Warnings

Health Smart Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NA

Active Ingredient(s)

Ethyl Alcohol 62%

Purpose

Antimicrobial

Use

Helps reducing bacteria that potentially can cause disease

Recommended for repeated use

Warnings

For external use only

Flammable. Keep away from fire or flame

WHEN USING

When using this product do not use in or near eyes. In case of eye contact, flush eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or redness develops and lasts for more than 72 hours

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

Place enough product in your palm to thoroughly cover your hands.

Rub hands together briskly untill dry

Children under six years of age should be supervised when using this product

Other information

Store below 110F (43C)

May discolor certain fabrics or surfaces

Inactive ingredients

Water, aloe barbadensis gel, carbomer, fragrance, glycerin, triethanolamine, tocopheryl acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALTH SMART INSTANT HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75112-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75112-003-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020
2	NDC: 75112-003-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020
3	NDC: 75112-003-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020
4	NDC: 75112-003-04	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020
5	NDC: 75112-003-05	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020
6	NDC: 75112-003-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020
7	NDC: 75112-003-07	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020
8	NDC: 75112-003-08	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/22/2020

Labeler - Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch (414137820)

Registrant - Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch (414137820)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch		414137820	manufacture(75112-003)