SUMMIT HAND SANITIZER- alcohol gel 
IMO SOURCE (PTY) 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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Summit Soap Hand Sanitizer

Drug Facts

Active ingredient(s)

Ethyl Alcohol 70% (V/V%)

Purpose

Antiseptic

Use[s]

Warnings

For external use only

• Flammable

• Keep away from fire or flame

Do not use

  • On children less than 2 months of age
  • On open skin wounds

When using this product

  • Keep out of eyes. In case of contact with eyes, flush thoroughly with water
  • Avoid contact with broken skin
  • Do not inhale or ingest

Stop use and ask a doctor if

irritation, rash or redness develops and persists

Keep out of reach of children

  • If swallowed, seek medical help or contact a Poison Control Center immediately

Directions

Other information

Inactive Ingredients

Purified water USP, Glycerol, Hydroxyethylcellulose , Tocopheryl Acetate (Vitamin E), Benzalkonium Chloride, Tetrasodium EDTA, Citric Acid.

Package Labeling

Bottle

SUMMIT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79190-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79190-000-015000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/30/2020
Labeler - IMO SOURCE (PTY) LTD (557388658)

Revised: 6/2020
Document Id: a93dca91-ea0d-6bca-e053-2a95a90a5d2e
Set id: 036d61c1-7db0-4155-babd-075c832907e9
Version: 1
Effective Time: 20200629
 
IMO SOURCE (PTY) LTD