ADVANCED HAND SANITIZER- alcohol gel 
DEALMED MEDICAL SUPPLIES LLC

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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Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin that can cause disease. recommended for repeat use

Warnings

Flammable. Keep away from heat or flame, For external use only.

Do not use

Do not use in or near the eyes. in case of contact, rinse thorougly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

Directions

Other information

Inactive ingredients

Water, Carprylyl Glycol, Aloe Vera, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Yellow 5 and Blue 1.

Package Label - Principal Display Panel

3.78L Label3.78 L NDC: 78257-919-01

ADVANCED HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78257-919
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
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78257-919-013780 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/16/2020
Labeler - DEALMED MEDICAL SUPPLIES LLC (078864775)
Establishment
NameAddressID/FEIBusiness Operations
PELICAN GROUP LLC, THE078435913manufacture(78257-919)

Revised: 11/2020
Document Id: b47d4c6e-1596-72c3-e053-2995a90aa6f2
Set id: b3dd272e-5f0d-5578-e053-2a95a90ad764
Version: 2
Effective Time: 20201119
 
DEALMED MEDICAL SUPPLIES LLC