HAND SANITIZER- ethyl alcohol gel 
India Glycols Limited

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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IG SURF 5073 HAND SANITIZER GEL 1000 liter

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

  • hand sanitizer to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water not available

Warnings

For external use only. Flammable. Keep away from fire/flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

do not get into eyes . In case of contact. rinse eyes throughly with water

  • irritataion and redness develop
  • condition persist for more than 72 hours

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

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

water,glycerine,carbomer,aloe vera,amino methyl propanol, fragrance, hydrogen peroxide, denatonium benzoate, tocopherol, tert-butyl alcohol

Topical Application

Wet hands thoroughly with product and allow to dry without wiping

Package Label - Principal Display Panel

1000 Literl NDC: 80837-001-10 BackFront

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80837-002
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
GLYCERIN (UNII: PDC6A3C0OX) 1.25 mL  in 100 mL
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 27.5 mL  in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.04 mL  in 100 mL
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.03 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.2 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
ALOE VERA WHOLE (UNII: KIZ4X2EHYX) 0.25 mL  in 100 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.02 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80837-002-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2020
2NDC:80837-002-121000000 mL in 1 DRUM; Type 0: Not a Combination Product10/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/18/2020
Labeler - India Glycols Limited (862323219)

Revised: 10/2020
Document Id: b213e81f-c4be-a4dd-e053-2a95a90a8897
Set id: b1dac821-3044-5d0c-e053-2995a90ac36f
Version: 2
Effective Time: 20201020
 
India Glycols Limited