78536-004 75% Alcohol Instant Sanitizer Wipes

Sanitizing Wipes by

Drug Labeling and Warnings

Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by Zhejiang Yiwu Mingou Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANITIZING 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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78536-004 75% Alcohol Instant Sanitizer Wipes

Ethyl Alcohol 75%

Antiseptic

USE

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

Warning

Flammable, Keep away from fire or flame. For external
Do not use in or contact the eyes.
Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases.

●Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Open lid, gently pull back resealable label, remove and use wipe as required.
Reseal back after use to avoid evaporation of alcohol.

Inactive ingredients

Water, Glycerin, Vitamin E

SANITIZING WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78536-004
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
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78536-004-05	80 in 1 CARTON	08/05/2020
1		25 in 1 BAG
1		124.62 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC: 78536-004-09	24 in 1 CARTON	08/05/2020
2		100 in 1 BOTTLE
2		498.5 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC: 78536-004-10	12 in 1 CARTON	08/05/2020
3		120 in 1 BOTTLE
3		598.2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4	NDC: 78536-004-03	108 in 1 CARTON	08/05/2020
4		15 in 1 BAG
4		74.77 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5	NDC: 78536-004-06	36 in 1 CARTON	08/05/2020
5		50 in 1 BAG
5		249.25 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
6	NDC: 78536-004-04	80 in 1 CARTON	08/05/2020
6		20 in 1 BAG
6		99.7 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
7	NDC: 78536-004-07	36 in 1 CARTON	08/05/2020
7		60 in 1 BAG
7		299.1 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
8	NDC: 78536-004-08	24 in 1 CARTON	08/05/2020
8		80 in 1 BAG
8		398.8 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
9	NDC: 78536-004-02	200 in 1 CARTON	08/05/2020
9		10 in 1 BAG
9		49.85 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
10	NDC: 78536-004-01	15 in 1 CARTON	08/05/2020
10		100 in 1 BOX
10		5 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	08/05/2020	08/28/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Yiwu Mingou Biotechnology Co., Ltd.		554535538	manufacture(78536-004)

Revised: 8/2020

Document Id: ade56d10-ea3c-47ca-e053-2995a90ad7ad

34390-5

Set id: aad5aebb-fa04-e7a4-e053-2a95a90a6d20

Version: 4

Effective Time: 20200827

 

Zhej