INSTANT HAND SANITIZER CITRUS ZEST- ethyl alcohol liquid

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Universal Distribution Center LLC
INN (International Name):
ALCOHOL
Composition:
ALCOHOL 70 mL in 100 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antimicrobial Use - Hand sanitizer to help reduce bacteria on the skin. Stop use and ask a doctor if irritation or rash appears and lasts.
Authorization status:
OTC monograph not final
Authorization number:
52000-018-01, 52000-018-29, 52000-018-30, 52000-018-31, 52000-018-32, 52000-018-33, 52000-018-34, 52000-018-35

INSTANT HAND SANITIZER CITRUS ZEST- ethyl alcohol liquid

Universal Distribution Center LLC

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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INSTANT HAND SANITIZER CITRUS ZEST

Active ingredient

Ethyl alcohol 70% v/v

Purpos e

Antimicrobial

Us e

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with

water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

away.

Directions

Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry.

Children under 6 years of age should be supervised when using this product.

Other information

Store below 106°F (41°C).

May discolor certain fabrics or surfaces.

Inactive ingredients

Water, glycerin, propylene glycol, fragrance, acrylates/c10-30 alkyl acrylate crosspolymer, isopropyl

alcohol, aminomethyl propanol, isopropyl myristate, caprylyl glycol, phenoxyethanol, tocopheryl

acetate, FD&C yellow no.5.

PRINCIPAL DISPLAY PANEL

INSTANT HAND SANITIZER CITRUS ZEST WITH VITAMIN E AND OTHER MOISTURIZERS

ANTIMICROBIAL

KILLS GERMS WITHOUT WATER

8 FL.OZ (236 mL)

INSTANT HAND SANITIZER CITRUS ZEST

ethyl alcohol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:520 0 0 -0 18

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

70 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

CARBO MER INTERPO LYMER TYPE A ( 550 0 0 CPS) (UNII: 59 TL3WG5CO)

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

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

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

Universal Distribution Center LLC

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:520 0 0 -0 18 -29

59 mL in 1 BOTTLE, PLASTIC

2

NDC:520 0 0 -0 18 -0 1

118 mL in 1 BOTTLE, PLASTIC

3

NDC:520 0 0 -0 18 -30

236 mL in 1 BOTTLE, PLASTIC

4

NDC:520 0 0 -0 18 -31

29 5 mL in 1 BOTTLE, PLASTIC

5

NDC:520 0 0 -0 18 -32

354 mL in 1 BOTTLE, PLASTIC

6

NDC:520 0 0 -0 18 -33

472 mL in 1 BOTTLE, PLASTIC

7

NDC:520 0 0 -0 18 -34

70 8 mL in 1 BOTTLE, PLASTIC

8

NDC:520 0 0 -0 18 -35

9 44 mL in 1 BOTTLE, PLASTIC

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

11/22/20 14

Labeler -

Universal Distribution Center LLC (019180459)

Revised: 12/2014

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