75109-506 Alcosm alcohol wipes 75% Alcohol

Mascon Alcohol Wipes by

Drug Labeling and Warnings

Mascon Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by Kangna (Zhejiang) Medical Supplies Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MASCON ALCOHOL WIPES- alcohol cloth 
Kangna (Zhejiang) Medical Supplies 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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75109-506 Alcosm alcohol wipes 75% Alcohol

Active Ingredient

Alcohol 75%

Purpose

Antiseptic

USE

For hand sanitizing to decrease bacteria on skin. Apply topically to skin to help prevent cross contamination.
Not recommended for repeated use. Dries in seconds.

Warning

For external use only. Flammable, keep away from fire or flame.
When using this product keep out of eyes, ears, and mouth. In case of eye contact, flush thoroughly with water.
Stop use and ask 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 immediately.

Directions

Remove lid. Pull wipe from center of roll and thread through opening in lid. Do not push finger through
opening. Replace lid, pull wipe up and then out at 45° angle. Next wipe dispenses automatically. Close lid to retain moisture.

Inactive ingredients

Water

MASCON ALCOHOL WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75109-506
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 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75109-506-01	12 in 1 CARTON	07/05/2020
1		50 in 1 BOX
1		1 in 1 PACKAGE
1		2.8 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC: 75109-506-02	100 in 1 CARTON	07/05/2020
2		10 in 1 PACKAGE
2		37.8 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC: 75109-506-03	24 in 1 CASE	07/05/2020
3		50 in 1 PACKAGE
3		189 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4	NDC: 75109-506-05	16 in 1 CARTON	07/05/2020
4		100 in 1 PACKAGE
4		378 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5	NDC: 75109-506-04	16 in 1 CARTON	07/05/2020
5		80 in 1 PACKAGE
5		302.4 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
6	NDC: 75109-506-06	12 in 1 CARTON	07/05/2020
6		100 in 1 BOX
6		1 in 1 PACKAGE
6		2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
7	NDC: 75109-506-07	24 in 1 CARTON	07/05/2020
7		50 in 1 BOX
7		1 in 1 PACKAGE
7		2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
8	NDC: 75109-506-08	200 in 1 BOX	07/05/2020
8		1 in 1 PACKAGE
8		2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
9	NDC: 75109-506-09	12 in 1 CARTON	07/05/2020
9		75 in 1 CANISTER
9		258.825 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
10	NDC: 75109-506-10	12 in 1 CARTON	07/05/2020
10		150 in 1 CANISTER
10		235.2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
11	NDC: 75109-506-11	12 in 1 CARTON	07/05/2020
11		240 in 1 CANISTER
11		471.59884 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
12	NDC: 75109-506-12	2 in 1 CARTON	07/05/2020
12		350 in 1 CANISTER
12		1796.258 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
13	NDC: 75109-506-13	4 in 1 CARTON	07/05/2020
13		800 in 1 PACKAGE
13		1515.136 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/05/2020	07/20/2020

Labeler - Kangna (Zhejiang) Medical Supplies Co., Ltd. (554530173)

Establishment
Name	Address	ID/FEI	Business Operations
Kangna (Zhejiang) Medical Supplies Co., Ltd.		554530173	manufacture(75109-506)

Revised: 7/2020

Document Id: aaef6a05-c077-8a76-e053-2a95a90a1fb8

34390-5

Set id: a9bb1435-3e4b-cf52-e053-2a95a90a535e

Version: 2

Effective Time: 20200721

 

Kang