BIOSERICA ERA ALCOHOL WIPES- alcohol cloth

Bioserica ERA Alcohol Wipes by

Drug Labeling and Warnings

Bioserica ERA Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by Guangzhou Shentai Hygienic Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Bioserica®ERA Alcohol Wipes

Active Ingredient(s)

Alcohol 4mL/pcs. Purpose: Antiseptic

Purpose

Antiseptic, Bioserica®ERA Alcohol Wipes

Use

Bioserica®ERA Alcohol 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

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

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

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 until it is dry. Do not rinse with water immediately.
• 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

purified water USP

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

BIOSERICA ERA ALCOHOL WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77119-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	4 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77119-101-01	50 in 1 BAG; 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 not final	part333A	03/30/2020

Labeler - Guangzhou Shentai Hygienic Products Co., Ltd. (529067056)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Shentai Hygienic Products Co., Ltd.		529067056	manufacture(77119-101)