ALCOHOL WIPES- alcohol cloth
Zhejiang Yiwu Mingou Biotechnology 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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78536-003 75% Alcohol Wipes

Ethyl Alcohol 75%

Antiseptic

USE

Use: Health care personnel hand rub to help
reduce bacteria that potentially can cause disease.

Warning

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.
●if case of contact with eyes, rinse
eyes thoroughly with water
Stop use and ask a doctor if
●irritation and redness develop. 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

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.

Inactive ingredients

25% Pure Water

ALCOHOL WIPES
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78536-003
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 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78536-003-05	12 in 1 CARTON	07/07/2020
1		150 in 1 BAG
1		810 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC:78536-003-09	30 in 1 CARTON	07/07/2020
2		100 in 1 BOTTLE
2		540 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC:78536-003-10	30 in 1 CARTON	07/07/2020
3		80 in 1 BOTTLE
3		432 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4	NDC:78536-003-03	24 in 1 CARTON	07/07/2020
4		84 in 1 BAG
4		454 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5	NDC:78536-003-06	12 in 1 CARTON	07/07/2020
5		160 in 1 BAG
5		864 mL in 1 POUCH; Type 0: Not a Combination Product
6	NDC:78536-003-04	12 in 1 CARTON	07/07/2020
6		140 in 1 BAG
6		756 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
7	NDC:78536-003-07	12 in 1 CARTON	07/07/2020
7		170 in 1 BAG
7		918 mL in 1 POUCH; Type 0: Not a Combination Product
8	NDC:78536-003-08	12 in 1 CARTON	07/07/2020
8		180 in 1 BAG
8		972 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
9	NDC:78536-003-01	24 in 1 CARTON	07/07/2020
9		48 in 1 BAG
9		260 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
10	NDC:78536-003-02	24 in 1 CARTON	07/07/2020
10		64 in 1 BAG
10		346 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product

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

Labeler - Zhejiang Yiwu Mingou Biotechnology Co., Ltd. (554535538)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Yiwu Mingou Biotechnology Co., Ltd.		554535538	manufacture(78536-003)