75% Alcohol Instant Hand Sanitizer by Hangzhou Wellbeing Technology Co., Ltd.

75% Alcohol Instant Hand Sanitizer by

Drug Labeling and Warnings

75% Alcohol Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Hangzhou Wellbeing Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

75% ALCOHOL INSTANT HAND SANITIZER- hand sanitizer gel 
Hangzhou Wellbeing Technology Co., 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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Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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

Inactive ingredients

aloe, carbomer, glycerin, sterile distilled water.

Package Label - Principal Display Panel

100 mL NDC: 78416-016-02

Package Label - Principal Display Panel

500 mL NDC: 78416-016-04

75% ALCOHOL INSTANT HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78416-016
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
GLYCERIN (UNII: PDC6A3C0OX)	3 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.12 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	21.79 mL  in 100 mL
ALOE (UNII: V5VD430YW9)	0.09 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78416-016-02	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/04/2020
2	NDC: 78416-016-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/04/2020	12/31/2021

Labeler - Hangzhou Wellbeing Technology Co., Ltd. (414010999)

Registrant - Hangzhou Wellbeing Technology Co., Ltd. (414010999)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Wellbeing Technology Co., Ltd.		414010999	manufacture(78416-016)

Revised: 4/2022

Document Id: dd39bd45-b14a-3fc6-e053-2995a90a9d64

34390-5

Set id: a73e5609-3c25-55c8-e053-2995a90af02e

Version: 3

Effective Time: 20220422