Alcohol wipes by Xiamen Ekem Tech.co.,ltd.

Alcohol wipes by

Drug Labeling and Warnings

Alcohol wipes by is a Otc medication manufactured, distributed, or labeled by Xiamen Ekem Tech.co.,ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL WIPES- hand sanitizer cloth 
Xiamen Ekem Tech.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% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Alcohol Antiseptic Wipes 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

• Wipe the surface of the skin with a damp paper towel until it is dry. Do not rinse with water immediately after wiping.
• 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 Barbadensis Leaf Juice, Glycerin, Vitamin E, Water(Aqua).

Package Label - Principal Display Panel

80 Wipes in 1 PAIL NDC: 79429-001-01

Package Label - Principal Display Panel

100 Wipes in 1 PAIL NDC: 79429-001-02

ALCOHOL WIPES 
hand sanitizer cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79429-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.1 g  in 100 g
ALOE (UNII: V5VD430YW9)	0.03 g  in 100 g
WATER (UNII: 059QF0KO0R)	24.84 g  in 100 g
TOCOPHEROL (UNII: R0ZB2556P8)	0.03 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79429-001-01	358 g in 1 PAIL; Type 0: Not a Combination Product	07/03/2020	02/03/2023
2	NDC: 79429-001-02	448 g in 1 PAIL; Type 0: Not a Combination Product	07/03/2020	02/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/03/2020	02/03/2023

Labeler - Xiamen Ekem Tech.co.,ltd. (416208686)

Registrant - Xiamen Ekem Tech.co.,ltd. (416208686)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Ekem Tech.co.,ltd.		416208686	manufacture(79429-001)

Revised: 12/2021

Document Id: d38f9404-908d-e375-e053-2a95a90a883c

34390-5

Set id: a96dba3d-c196-62a0-e053-2a95a90ae0ed

Version: 3

Effective Time: 20211220