GERMISEPT ANTIBACTERIAL ALCOHOL WIPES- alcohol cloth
Jurong Dongfa General Merchandise 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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75127-103 Germisept Antibacterial Alcohol Wipes 150 wipes 75% Ethyl Alcohol

Drugs Fact

Active ingredient

Ethyl Alcohol 75%(v/v)

Purpose

Antiseptic

Uses:

For cleansing to decrease bacteria on skin.
Recommended for repeated use with a new unused wipe each time.
Dries quickly.

Warnings

Flammable,Keep away from fire or flame.
For external use only.

Do not use

in or contact the eyes.
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a physician.

Keep this out of reach of children.

unless under adult supervision.
If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Open the flip top lid, remove one wipe to use.
Wipe hands thoroughly with product and allow to dry without wiping.
Close filp top lid label after use to retain moisture.

Other information

Dispose of wipe in the proper container.
Do not flush down the toilet.

Inactive ingredients

Aloe Barbadensis Leaf Extract, Aqua (Purified & De-Ionized Water), Benzalkonium Chloride, Glycerin.

Package Labeling:

GERMISEPT ANTIBACTERIAL ALCOHOL WIPES
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75127-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75127-103-01	4 in 1 CARTON	12/10/2020
1		150 in 1 BAG
1		305 g 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	part333E	12/10/2020

Labeler - Jurong Dongfa General Merchandise Co., Ltd. (528077612)

Name	Address	ID/FEI	Business Operations
Establishment
Jurong Dongfa General Merchandise Co., Ltd.		528077612	manufacture(75127-103)