ZUUM KLIN ANTIBACTERIAL- alcohol gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
U.S. Cotton Mexico, S. de R.L. de C.V.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For hand washing to decrease bacteria on the skin
Authorization status:
OTC monograph not final
Authorization number:
77388-001-01

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ZUUM KLIN ANTIBACTERIAL- alcohol gel

U.S. Cotton Mexico, S. de R.L. de C.V.

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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Zuum Klin Gel Antibacterial

Drug Facts

Active ingredient

Ethyl alcohol 63%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only

Flammable, keep away from fire or flame

Do not use

in the eyes

Stop use and ask a doctor

irritation and redness develop

condition persists for more than 72 hours

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

Keep this product away from heat, fire or sunlight.

Inactive ingredients

Isopropyl alcohol, deionized water, aloe vera (aloe barbadensis) extract, propylene glycol, carbomer,

aminomethyl propanol, fragrance, EDTA, vitamin E, vitamin A, ceramides

Questions or Comments?

Questions or Comments?

505-962-3014

Package Labeling:

ZUUM KLIN ANTIBACTERIAL

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7738 8 -0 0 1

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 .6 3 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

U.S. Cotton Mexico, S. de R.L. de C.V.

WATER (UNII: 0 59 QF0 KO0 R)

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

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

EDETIC ACID (UNII: 9 G34HU7RV0 )

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

VITAMIN A (UNII: 8 1G40 H8 B0 T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7738 8 -0 0 1-0 1 250 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 20

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

0 8 /0 1/20 20

Labeler -

U.S. Cotton Mexico, S. de R.L. de C.V. (816167605)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

U.S. Co tto n Mexico , S. de R.L. de C.V.

8 16 16 76 0 5

ma nufa c ture (7738 8 -0 0 1)

Revised: 11/2020

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