PURE CARE -ALCOHOL WIPES- pure care -alcohol wipes cloth
Jinhua Huihuang Non-woven Products 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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PURE CARE -ALCOHOL WIPES
100pcs 54016-020-12

Active Ingredient(s)

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Use

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

Warnings

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 with water.

Stop use and ask a doctor if irritation or rash occurs. These may be sign of a serious condition.

Keep out of reach of children, If 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

Other information

Store between 50-86℉(15-30℃)
Avoid freezing and excessive heat above 104℉(40℃)

Inactive ingredients

Purified water

Package Label - Principal Display Panel

100pcs NDC: 54016-020-12 100pcs label_1 100pcs label_2

PURE CARE -ALCOHOL WIPES
pure care -alcohol wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54016-020
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:54016-020-12	100 in 1 PACKET	12/10/2020
1		5.5 mL in 1 PATCH; 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	part333E	12/10/2020

Labeler - Jinhua Huihuang Non-woven Products Co., Ltd. (540165729)

Name	Address	ID/FEI	Business Operations
Establishment
Jinhua Huihuang Non-woven Products Co., Ltd.		540165729	manufacture(54016-020)

Name	Address	ID/FEI	Business Operations
Establishment
Gourmet Home Products, LLC		962068677	label(54016-020)

PURE CARE -ALCOHOL WIPES 100pcs 54016-020-12