NewReba, Hand Sanitizer, Gel, 80% Ethyl alcohol, 473mL

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Jiangsu New Reba Technology Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Jiangsu New Reba Technology Inc.

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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NewReba, Hand Sanitizer, Gel, 80% Ethyl alcohol, 473mL

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

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

Warnings

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

Do not use

• on 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.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

Glycerol, Aloe extract, Sodium Hyaluronate, Acrylic Acid Polymers, Trolamine, Water (aqua)

Package Label - Principal Display Panel

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83141-0014
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83141-0014-1	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/05/2022	02/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/05/2022	02/13/2023

Labeler - Jiangsu New Reba Technology Inc. (544096564)

Registrant - Jiangsu New Reba Technology Inc. (544096564)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu New Reba Technology Inc.		544096564	manufacture(83141-0014) , label(83141-0014)

Revised: 2/2023

Document Id: f4839080-06f9-bc94-e053-2a95a90a5e65

34390-5

Set id: eec2ee11-e5d6-0f53-e053-2995a90a2887

Version: 2

Effective Time: 20230213