75127-104 Germisept Antibacterial Alcohol Wipes75% Ethyl Alcohol

Germisept Antibacterial Alcohol Wipes by

Drug Labeling and Warnings

Germisept Antibacterial Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by Jurong Dongfa General Merchandise Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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75127-104 Germisept Antibacterial Alcohol Wipes75% 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: 75127-104
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75127-104-01	36 in 1 CARTON	12/20/2022
1		15 in 1 BAG
1		90 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 75127-104-02	24 in 1 CARTON	12/20/2022
2		50 in 1 BAG
2		305 g in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 75127-104-03	2 in 1 CARTON	12/20/2022
3		800 in 1 BAG
3		4370 g in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC: 75127-104-04	6 in 1 CARTON	12/20/2022
4		4 in 1 BAG
4		50 in 1 BAG
4		305 g in 1 PACKAGE; 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	part333E	12/20/2022

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

Establishment
Name	Address	ID/FEI	Business Operations
Jurong Dongfa General Merchandise Co., Ltd.		528077612	manufacture(75127-104)

Revised: 12/2022

Document Id: f0537334-089c-5013-e053-2a95a90a741e

34390-5

Set id: f053747e-f863-4ff4-e053-2a95a90a2a72

Version: 1

Effective Time: 20221221

 

Jur