CHOICE HAND SANITIZE- ethyl 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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Choice Hand Sanitizing Gel 183

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Keep out of reach of 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.

Usage

Uses

Warnings

Warnings

Other Information

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

May discolor certain fabrics and surfaces.

Stop Usage

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

Administration

Directions

Inactive Ingredients

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

Choice Box Container

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, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

Choice

HAND SANITIZING GEL

Aloe Ver

  And

Vitamin E

Instant

Waterless

Contains

Moisturizers

PN 5025-404UV-CH

800m 

Hand sanitizing gel

  • Contains Aloe Vera and Vitamin E
  • Instant waterless with moisturizers
  • Produced in an FDA registered facility
  • cGMP facility
  • Dries quickly leaving the skin feeling soothed and moisturized

Kills

99.9% of

Germs

MADE IN THE USA

Choice

Dispenser Loading Instructions

Section 1Section 2Section 3Section 4

      Section 1                                 Section 2                           Section 3                           Section 4

Choice Box

Choice Case

                                                                                5025-CH-CS         Rev. 1.0

Choice™

HAND SANITIZING GEL                   Kills 99.9% of Germs

Instant Waterless                             Aloe Ver and Vitamin E

Contains Moisturizers

MADE IN THE USA                           5025-404UV-CH

                                                                12/800 ML UV                   040232 65077 2

Choice Case

CHOICE  HAND SANITIZE
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-183
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58575-183-01800 mL in 1 POUCH; Type 0: Not a Combination Product01/02/202007/11/2024
2NDC:58575-183-029600 mL in 1 CASE; Type 0: Not a Combination Product01/02/202007/11/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/02/202007/11/2024
Labeler - Inopak. Ltd (194718243)
Establishment
NameAddressID/FEIBusiness Operations
Inopak. Ltd194718243manufacture(58575-183)

Revised: 2/2023
Document Id: f51751ff-fab2-aaf1-e053-2995a90a5a8e
Set id: 0e79d928-6c3d-45e6-bdef-a13fec91fe64
Version: 2
Effective Time: 20230219
 
Inopak. Ltd