79864-001 Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by guangdong leiqi cosmetic company ltd,.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- hand sanitizer gel 
guangdong leiqi cosmetic company 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.

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79864-001
Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

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

Warnings

Do not use

Do not use in children less than 2 months of age, nor 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.

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. Children under 6 years of age should be supervised when using this product.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
May discolor certain fabrics or surfaces

Inactive ingredients

WATER, GLYCERIN, ACRYLATES COPOLYMER, TRIETHANOLAMINE, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, ROSA CENTIFOLIA FLOWER WATER, ALOE YOHJYU MATSU EKISU

Package Label - Principal Display Panel

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79864-001
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
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79864-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 79864-001-02	40 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 79864-001-03	55 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 79864-001-04	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 79864-001-05	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 79864-001-06	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 79864-001-07	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 79864-001-08	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC: 79864-001-09	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC: 79864-001-10	1000 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	01/15/2021

Labeler - guangdong leiqi cosmetic company ltd,. (531152452)

Establishment
Name	Address	ID/FEI	Business Operations
guangdong leiqi cosmetic company ltd,.		531152452	manufacture(79864-001)

Revised: 1/2021

Document Id: b8e854ff-2436-ecfa-e053-2995a90aee6e

34390-5

Set id: ac919e3b-5f26-e404-e053-2995a90a16d2

Version: 4

Effective Time: 20210114