helpmate Hand Sanitizer by Xiamen Wally Bath Manufacture Co., Ltd

helpmate Hand Sanitizer by

Drug Labeling and Warnings

helpmate Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Xiamen Wally Bath Manufacture Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HELPMATE HAND SANITIZER- alcohol denat. liquid 
Xiamen Wally Bath Manufacture Co., Ltd

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Active Ingredient(s)

Alcohol denat.70% 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

glycerin, purified water USP, PEG-40 Hydrogenated Castor Oil, Carbomer, Aminomethyl propanol, Aloe Barbadensis Leaf Extract

Package Label - Principal Display Panel

60ml package ndc: 78868-005-01

30ml package ndc: 78868-005-02

HELPMATE HAND SANITIZER 
alcohol denat. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78868-006
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
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78868-006-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 78868-006-02	30 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 Drug	M003	03/30/2020	12/01/2023

Labeler - Xiamen Wally Bath Manufacture Co., Ltd (548232606)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Wally Bath Manufacture Co., Ltd		548232606	manufacture(78868-006)

Revised: 7/2024

Document Id: 1cb83e07-ea15-e12e-e063-6394a90a49a4

34390-5

Set id: be40af7e-86f4-0486-e053-2995a90a6de1

Version: 3

Effective Time: 20240708