GERMISEPT ANTIBACTERIAL ALCOHOL WIPES- alcohol cloth

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Jurong Dongfa General Merchandise Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- For cleansing to decrease bacteria on skin. - Recommended for repeated use with a new unused wipe each time. - Dries quickly.
Authorization status:
OTC monograph not final
Authorization number:
75127-100-01

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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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75127-100 Germisept Antibacterial Alcohol Wipes 75% Ethyl Alcohol

Drugs Fact

Active ingredient

Ethyl Alcohol 75%(v/v)

Purpos e

Antiseptic

Us es :

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:75127-10 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

0 .75 mL in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

WATER (UNII: 0 59 QF0 KO0 R)

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

GLYCERIN (UNII: PDC6 A3C0 OX)

Jurong Dongfa General Merchandise Co., Ltd.

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:75127-10 0 -

6 in 1 CARTON

12/10 /20 20

1

4 in 1 CANISTER

1

50 in 1 BAG

1

30 5 g in 1 NOT APPLICABLE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

12/10 /20 20

Labeler -

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

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Juro ng Do ngfa General Merchandise Co ., Ltd.

528 0 776 12

ma nufa c ture (75127-10 0 )

Revised: 12/2020

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