ALCOHOL WIPES- alcohol wipes cloth
Guangdong Bolicen Bio-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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ALCOHOL WIPES

Active Ingredient(s)

Alcohol75%v/v

Purpose

Antiseptic

Use

Use for hand disinfecting and cleaning when soap and water are not availableI.

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

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

STORAGE AND HANDLING SECTION
Store between 15-30°C(59-86F).
Avoid freezing and excessive heat above 40°C(104F).

Inactive ingredients

Water

Package Label - Principal Display Panel

100

ALCOHOL WIPES
alcohol wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78293-006
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78293-006-01	8 a in 1 BAG; Type 0: Not a Combination Product	03/30/2020
2	NDC:78293-006-02	30 a in 1 BAG; Type 0: Not a Combination Product	03/30/2020
3	NDC:78293-006-03	50 a in 1 BAG; Type 0: Not a Combination Product	03/30/2020
4	NDC:78293-006-04	80 a in 1 BAG; Type 0: Not a Combination Product	03/30/2020
5	NDC:78293-006-05	100 a in 1 BAG; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - Guangdong Bolicen Bio-Technology Co., Ltd. (554525110)

Name	Address	ID/FEI	Business Operations
Establishment
Guangdong Bolicen Bio-Technology Co., Ltd.		554525110	manufacture(78293-006)