ENCORE HAND SANITIZING GEL- alcohol gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Inopak, Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic - To decrease bacteria on the skin that potentially can cause disease - Recommended for repeated use Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.
Authorization status:
OTC monograph not final
Authorization number:
58575-136-01, 58575-136-02

ENCORE HAND SANITIZING GEL- alcohol gel

Inopak, 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.

----------

Encore Hand Sanitizing Gel 136

Active Ingredient

Alcohol 70% v/v

Purpos e

Antiseptic

Keep from Children

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

right away. Children should be supervised by an adult when using this product.

Directions

Us es

To decrease bacteria on the skin that potentially can cause disease

Recommended for repeated use

Warnings

Flammable, keep away from heat or flame.

For external use only.

Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

Safety information

May discolor certain fabrics and surfaces.

Stop use

Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72

hours.

Directions

Apply sufficient amount of product to your palm to cover both hands.

Rub until dry.

Inactive ingredients

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol,

D&C Blue 1, FD&C Yellow 5, Fragrance, PEG/PPG-18/18 Dimethicone, Purified Water, Vitamin E

Encore Front label

instant waterless

HAND

SANITIZING

With moisturizers

WITH ALOE VERA

& VITAMIN E

KILLS 99.99% OF GERMS!

Dries quickly, leaving skin feeling

soothed and moisturized

ENCORE

INDUSTRIAL PRODUCTS 2 oz.

Encore Back label

Drug Facts

Active Ingredient Purpose

Ethyl Alcohol 70% v/v …………….. Antiseptic

Us es

To decrease bacteria on the skin that potentially can cause disease

Recommended for repeated use

Warnings

Flammable, keep away from heat or flame.

For external use only.

Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation and redness develop or if 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. Children should be supervised by an adult when using this product.

Directions

Apply sufficient amount of product to your palm to cover both hands.

Rub until dry.

Other Information

May discolor certain fabrics and surfaces.

Inactive Ingredients

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol,

D&C Blue 1, FD&C Yellow 5, Fragrance, PEG/PPG-18/18 Dimethicone, Purified Water, Vitamin E

Encore Industrial Products

3502 Bacor Rd. Houston, TX 77084

1-877-703-3044 www.encoreindustrial.com

Encore Case label

instant waterless

HAND SANITIZING GEL

With moisturizers

WITH ALOE VERA & VITAMIN E

KILLS 99.99% OF GERMS!

Dries quickly, leaving skin feeling soothed and moisturized

80/2oz. ENCORE Encore Industrial Products

INDUSTRIAL PRODUCTS 3502 Bacor Rd. Houston, TX 77084

1-877-703-3044

www.encoreindustrial.com

ENCORE HAND SANITIZING GEL

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 575-136

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

42 mL in 6 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PERFLUO RO ALKYLETHYL ACRYLATES ( C6 -C14 ) (UNII: TKA54G58 8 X)

ALO E (UNII: V5VD430 YW9 )

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

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

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

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

WATER (UNII: 0 59 QF0 KO0 R)

Inopak, Ltd

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:58 575-136 -

6 0 mL in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/0 1/20 18

2

NDC:58 575-136 -

48 0 0 mL in 1 CASE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 18

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 1/0 1/20 18

Labeler -

Inopak, Ltd (194718243)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ino pak, Ltc

19 4718 243

ma nufa c ture (58 575-136 )

Revised: 2/2020

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