ENCORE HAND SANITIZING GEL- alcohol gel

Encore by

Drug Labeling and Warnings

Encore by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Acitive Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Keep out of Childrens reach

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.

Uses

• 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.

Safety Information

May discolor certain fabrics and surfaces.

Stoppage

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

Encore Hand Sanitizing Gel Front 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

ENCORE

INDUSTRIAL PRODUCTS                2 oz.

Encore Hand Sanitizing Gel Back Label

Drug Facts

Active Ingredient                             Purpose

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

Uses

• 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 Hand Gel 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

4/1000ml             ENCORE                                           Encore Industrial Products

INDUSTRIAL PRODUCTS                3502 Bacor Rd. Houston, TX 77084

                                                                                1-877-703-3044

                                                                                www.encoreindustrial.com

INGREDIENTS AND APPEARANCE

ENCORE  HAND SANITIZING GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-137
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	700 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
PERFLUOROALKYLETHYL ACRYLATES (C6-C14) (UNII: TKA54G588X)
ALOE (UNII: V5VD430YW9)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-137-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-137-02	4000 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018	02/01/2020
3	NDC: 58575-137-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2018

Labeler - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-137)