ALCOHOL-BASED DISINFECTANT HAND SANITIZER- alcohol-based disinfectant hand sanitizer gel
Foshan Lang-Yeon Trade Limited Company

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.

----------

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antimicrobial

Purpose

Purpose: Antimicrobial , Hand Sanitizer

Use

Pour a suitable amount of gel onto the palm of your hand and rub hands together thoroughly. Gel will evaporate. No need to rinse or dry hands after use

Warnings

Keep out of reach of children This product is highly flammable Keep away from open flame or fire Avoid contact with eyes and mucous membranes Harmful if swallowed

Do not use

Directions

This product has a strong inhibitoryffect on various bacteria and virusesincluding Staphylococcus Aureus,

Pseudomonas Aeruginosa, CandidaAlbcans and Escherichia Coli

Other information

Keep in a cool, dry and well ventilated area away from direct sunlight

Inactive ingredients

Water, Glycerin, Carbomer,Triethanolamine, Lavender Essence

Package Label - Principal Display Panel

300 3000 120

236 250 500 1000 2000 4000 5000

ALCOHOL-BASED DISINFECTANT HAND SANITIZER
alcohol-based disinfectant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79606-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
LAVENDER OIL (UNII: ZBP1YXW0H8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79606-002-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
2	NDC:79606-002-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
3	NDC:79606-002-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
4	NDC:79606-002-02	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
5	NDC:79606-002-05	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
6	NDC:79606-002-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
7	NDC:79606-002-07	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
8	NDC:79606-002-08	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
9	NDC:79606-002-09	3000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
10	NDC:79606-002-10	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
11	NDC:79606-002-11	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/10/2020

Labeler - Foshan Lang-Yeon Trade Limited Company (554537424)

Name	Address	ID/FEI	Business Operations
Establishment
GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD		540725476	manufacture(79606-002)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Lang-Yeon Trade Limited Company		554537424	label(79606-002)