CUCUMBER HAND GEL 70% ETOH- V/V gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Alpha Aromatics
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic; Hand Sanitizer Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. in children less than 2 months of age on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious conditions.
Authorization status:
OTC monograph not final
Authorization number:
75009-272-01, 75009-272-02, 75009-272-03, 75009-272-04, 75009-272-05

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CUCUMBER HAND GEL 70% ETOH (V/V)- cucumber hand gel 70% etoh (v/v) gel

Alpha Aromatics

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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Cucumber Hand Gel 70% ETOH (v/v)

Active Ingredient(s)

Alcohol 70% (v/v) Purpose: Antiseptic

Purpos e

Antiseptic; Hand Sanitizer

Us e

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water

are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

in children less than 2 months of age

on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes

thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious conditions.

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

away.

Directions

Place a dime sized amount in hands. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15 - 30C (59-84F)

Avoid freezing and excessive heat above 40C (104 F)

Inactive ingredients

purified USP water, carbomer, fragrance

Package Label - Principal Dispaly Panel

936ml NDC: 75009-272-01

3780ml NDC: 75009-272-02

18920ml NDC: 75009-272-03

208190ml NDC: 75009-272-04

1040980ml NDC: 75009-272-05

CUCUMBER HAND GEL 70% ETOH (V/V)

cucumber hand gel 70% etoh (v/v) gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:750 0 9 -272

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

CYCLAMEN ALDEHYDE (UNII: 4U37UX0 E1E)

0 .0 0 4 mL in 10 0 mL

WATER (UNII: 0 59 QF0 KO0 R)

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

LINALO O L, ( +) - (UNII: F4VNO44C0 9 )

0 .0 0 2 mL in 10 0 mL

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing

Start Date

Marketing End

Date

1

NDC:750 0 9 -

272-0 1

9 46 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/0 1/20 20

2

NDC:750 0 9 -

272-0 2

378 0 mL in 1 JUG; Type 0 : No t a Co mbinatio n Pro duct

11/0 1/20 20

3

NDC:750 0 9 -

272-0 3

18 9 20 mL in 1 PAIL; Type 0 : No t a Co mbinatio n Pro duct

11/0 1/20 20

Alpha Aromatics

4

NDC:750 0 9 -

272-0 4

20 8 19 0 mL in 1 DRUM; Type 0 : No t a Co mbinatio n Pro duct

11/0 1/20 20

5

NDC:750 0 9 -

272-0 5

10 40 9 8 0 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0 :

No t a Co mbinatio n Pro duct

11/0 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 rt333A

11/0 1/20 20

Labeler -

Alpha Aromatics (041723545)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Alpha Aro matics

0 41723545

ma nufa c ture (750 0 9 -272)

Revised: 9/2020

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