HAND SANITIZER- alcohol gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Fareva Morton Grove, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic 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 and redness develops and persists.
Authorization status:
OTC monograph not final
Authorization number:
72686-188-05

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HAND SANITIZER- alcohol gel

Fareva Morton Grove, Inc.

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.

----------

a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (77%, volume/volume (v/v)) in an

aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27

CFR part 20.

b. Glycerin

c. FRAGRANCE (PARFUM)

d. ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

e. ALOE BARBADENSIS LEAF JUICE

f. AMINOMETHYL PROPANOL

g. RED 4 (CI 14700)

h. CITRIC ACID

i. SODIUM BENZOATE

j. POTASSIUM SORBATE

Active Ingredient(s)

Alcohol 78% v/v. Purpose: Antiseptic

Purpos e

Antiseptic

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 and redness develops and persists.

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

away.

Directions

Place enough product on hands to cover all surfaces. 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 (59-86F)

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

Inactive ingredients

Acrylates/C10-30 Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Citric

Acid, Fragrance, Glycerin, Potassium Sorbate, Red 4 (CI 14700), Sodium Benzoate, Water

Package Label - Principal Display Panel

50 mL NDC: 72686-188-05

HAND SANITIZER

alcohol gel

Fareva Morton Grove, Inc.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:726 8 6 -18 8

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

78 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

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

GLYCERIN (UNII: PDC6 A3C0 OX)

FRAGRANCE JUNIPERBERRY O RANGE O RC2 0 0 0 8 4 3 (UNII: 2KS3NF0 8 B2)

WATER (UNII: 0 59 QF0 KO0 R)

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

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

ALO E (UNII: V5VD430 YW9 )

FD&C RED NO . 4 (UNII: X3W0 AM1JLX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:726 8 6 -18 8 -0 5

50 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

12/15/20 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

12/15/20 20

Labeler -

Fareva Morton Grove, Inc. (116752326)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Fareva Mo rto n

Gro ve, Inc

116 752326

manufacture(726 8 6 -18 8 ) , analysis(726 8 6 -18 8 ) , label(726 8 6 -18 8 ) , pack(726 8 6 -18 8 ) ,

relabel(726 8 6 -18 8 ) , repack(726 8 6 -18 8 )

Revised: 12/2020

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