SANITIZING WIPES- isopropanol cloth
Zhejiang Fanjia Medical Equipment 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.

----------

75 isopropanol fanjia

Active Ingredient(s)

Isopropanol 75% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial

Inactive ingredients

WATER

Uses

Suitable for skin cleaning and sterilization

Warnings

For external use only.

Flammable,keep away from fire or flame

Do not use

on open skin wounds

When using this product, avoid contact with eyes.In case of contact with eyes, rinse with water to remove.

Stop use and ask a doctor if irritation or redness develop.

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

Directions

Wet hands thoroughly with product and allow to dry without wiping

Other information

Do not store above 110F
May discolor some fabrics

Package Label - Principal Display Panel

160PCS NDC 80991-002-01 fanjia iso

160PCS NDC 80991-002-02 002-01

SANITIZING WIPES
isopropanol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80991-002
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 g in 100 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80991-002-01	160 in 1 POUCH	11/03/2020
1		1.5 g in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC:80991-002-02	160 in 1 CANISTER	11/03/2020
2		5 g in 1 APPLICATOR; 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	11/03/2020

Labeler - Zhejiang Fanjia Medical Equipment Co., Ltd. (554552225)

Registrant - Zhejiang Fanjia Medical Equipment Co., Ltd. (554552225)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Fanjia Medical Equipment Co., Ltd.		554552225	manufacture(80991-002) , label(80991-002)