MEDICALLY MINDED- alcohol gel 
SBL 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)

ACTIVEAlcohol 70% v/v. Purpose: ANTIMICROBIAL

Purpose

AntIMICROBIAL PURPUSE, Hand Sanitizer

Use

USAGEHand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGSFor external use only. Flammable. Keep away from heat or flame

Do not use

USINGWhen using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

STOPStop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Other information

Inactive ingredients

INACTIVEWATER, TRIETHANOLAMINE, CARBOMER

Package Label - Principal Display Panel

FRONTHAND SANITIZER GEL

6.5 FL OZ (194 ML)

MEDICALLY MINDED 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76619-110
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
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA) 0.0004 mL  in 1 mL
CARBOMER 934 (UNII: Z135WT9208) 0.004 mL  in 1 mL
WATER (UNII: 059QF0KO0R) 0.2956 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76619-110-04194 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - SBL LLC (117341346)
Registrant - SBL LLC (117341346)

Revised: 5/2020
Document Id: a493eadb-3e3b-2476-e053-2995a90ac70d
Set id: a49486ac-a82e-55c3-e053-2a95a90a0021
Version: 1
Effective Time: 20200501
 
SBL LLC