Hand Sanitizer by Omni Distributors, LLC / Ningbo Meiteli Cosmetic Co., Ltd

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Omni Distributors, LLC, Ningbo Meiteli Cosmetic Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol liquid 
Omni Distributors, LLC

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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Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• 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 in your palm and rub hands together briskly until dry

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Aloe Barbadensis Leaf Juice, Carbome, Glycerin

Package Label - Principal Display Panel

59 mL NDC: 79624-001-01

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79624-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79624-001-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	06/30/2023
2	NDC: 79624-001-02	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	06/30/2023
3	NDC: 79624-001-03	479 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	06/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	06/30/2023

Labeler - Omni Distributors, LLC (117528966)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Meiteli Cosmetic Co., Ltd		546624772	manufacture(79624-001)

Revised: 7/2022

Document Id: e4a3b3bd-3ca8-4bdc-e053-2a95a90af411

34390-5

Set id: ab78a507-aebf-292f-e053-2995a90ae58f

Version: 6

Effective Time: 20220725