Hand santiser by Yiwu city jieyi cleaning supplies co., LTD HAND SANTISER gel

Hand santiser by

Drug Labeling and Warnings

Hand santiser by is a Otc medication manufactured, distributed, or labeled by Yiwu city jieyi cleaning supplies co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Ethyl Alchol 75%(antiseptic）

Purpose

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Use

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Warnings

FOR EXTERNAL USE ONLY
Avoid contact with eyes. If eye contact occurs, flush with water. Keep out of direct sunligh.

Do not use

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WHEN USING

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STOP USE

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KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Directions

pump onto gands, latre vigorously for at least 15 seconds, rinse&dry throughly.

Inactive ingredients

Water, TriethanolamineCarbomer, ALoe vera Gel, Fragrance, Glycerol, Propylene, Glycol, VitaminE

Package Label - Principal Display Panel

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INGREDIENTS AND APPEARANCE

HAND SANTISER 
hand santiser gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76881-005
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
1-O-(2-METHOXY-4-HEXADECENYL)GLYCEROL (UNII: 3A7RDO6AC4)
.ALPHA.-TOCOPHEROL SUCCINATE, DL- (UNII: 7VJE08U49E)
DETOSU/TRIETHYLENE GLYCOL/TRIETHYLENE GLYCOL POLYGLYCOLIDE COPOLYMER (UNII: JC2Q67KRW7)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
3-(P-METHOXYPHENYL)PROPYLENE-1,2-OXIDE (UNII: 7K4661R4JM)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 1342 (UNII: 809Y72KV36)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76881-005-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 76881-005-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 76881-005-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 76881-005-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 76881-005-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 76881-005-06	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 76881-005-07	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Yiwu city jieyi cleaning supplies co., LTD (413161069)

Establishment
Name	Address	ID/FEI	Business Operations
Yiwu city jieyi cleaning supplies co., LTD		413161069	manufacture(76881-005)