PURE CARE HOUSEHOLD WIPES- isopropyl 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.

----------

78536-006 75% Isopropyl Alcohol Pure Care Household Wipes

Isopropyl Alcohol 75%

Antiseptic

USE

Wipe surface to help reduce bacteria that can potentially cause disease.

Warning

For external use only. Flammable,Keep away from heat or flame.
Do not use
·in children less than 2 month 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
lf irritation or rash occurs. These may be sign of a serious condition.

lf swallowed, get medical help or contact a Poison Control Center right away.

Directions

-Remove and unfold wipe
·Wipe surface thoroughly
·Dispose of used wipe in trash, do not flush

Inactive ingredients

Purified water

PURE CARE HOUSEHOLD WIPES
isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78536-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78536-006-05	18 in 1 CARTON	09/30/2020
1		140 in 1 PAIL
1		697.9 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC:78536-006-03	24 in 1 CARTON	09/30/2020
2		80 in 1 PAIL
2		398.8 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC:78536-006-04	24 in 1 CARTON	09/30/2020
3		100 in 1 PAIL
3		498.5 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4	NDC:78536-006-02	24 in 1 CARTON	09/30/2020
4		70 in 1 PAIL
4		349 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5	NDC:78536-006-01	24 in 1 CARTON	09/30/2020
5		100 in 1 BAG
5		498.5 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	09/30/2020

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

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Yiwu Mingou Biotechnology Co., Ltd.		554535538	manufacture(78536-006)