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.

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Encore Hand Sanitizing Gel

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 Front label

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 Gel Back label

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

Encore Hand Gel Case label

ENCORE  HAND SANITIZING GEL
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-137
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58575-137-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/201805/19/2021
2NDC:58575-137-024000 mL in 1 CASE; Type 0: Not a Combination Product01/01/201802/01/2020
3NDC:58575-137-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/201805/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/201805/19/2021
Labeler - Inopak, Ltd (194718243)
Establishment
NameAddressID/FEIBusiness Operations
Inopak, Ltd194718243manufacture(58575-137)

Revised: 5/2021
 
Inopak, Ltd