Alcohol Wipes by WellBe Si International Co., Ltd. WellBe, 001-01

Alcohol Wipes by

Drug Labeling and Warnings

Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by WellBe Si International Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL WIPES- alcohol cloth 
WellBe Si International 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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WellBe, 001-01

Active Ingredient(s)

Alcohol 75% . Purpose: Antiseptic

Purpose

Antiseptic

Use

To decrease bacteria on the skin.

Recommend for repeated use.

Warnings

For external use only.

When using this product keep away from the eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if irritation or redness develop for last more than 72 hours.

Keep out of reach of children. If swallowed get medical help or contact a poison control center immediately.

Stop use and ask a doctor if irritation or redness develop for last more than 72 hours.

Keep out of reach of children. If swallowed get medical help or contact a poison control center immediately.

Directions

Rub wipe over all surfaces of both hands and allow to dry. Supervise children under 6 years old.

Other information

Please keep away from fire or direct sunlight, and keep out of reach of children.

Inactive ingredients

Ethanol, Benzethonium Chloride, Zinc Pyrithione, Ethylhexylglycerin, 2-phenoxyethanol, Aloe Barbadensis Leaf Juice, Water

Package Label - Principal Display Panel

ALCOHOL WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81384-001
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

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
PYRITHIONE ZINC (UNII: R953O2RHZ5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81384-001-01	60 in 1 PACKET; Type 0: Not a Combination Product	01/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/05/2021	09/07/2022

Labeler - WellBe Si International Co., Ltd. (657260883)

Establishment
Name	Address	ID/FEI	Business Operations
WellBe Si International Co., Ltd.		657260883	manufacture(81384-001)

Revised: 9/2022

Document Id: e8210560-7042-4b26-e053-2995a90ae3d5

34390-5

Set id: b832d7c2-38e0-82b6-e053-2a95a90a363b

Version: 2

Effective Time: 20220907