HAND SANITIZER- alcohol gel 
LibertyWare 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)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

for handwashing to decrease bacteria on the skin.

Recommended for repeated use

Warnings

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

Do not use

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and 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.

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.

Directions

Other information

Inactive ingredients

distilled water, glycerin, rosemary, basil oil, aloe vera, vitamin e, azadirachtae indicae oil, essential oil, carbomer 940, tween 20

Package Label - Principal Display Panel

250 mL NDC: 90076-100-01

90076-100-01

1000 mL NDC: 90076-100-02

90076-100-02

5L NDC: 90076-100-03

90076-100-03

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90076-100
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 VERA LEAF (UNII: ZY81Z83H0X) 1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
ROSEMARY (UNII: IJ67X351P9) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 22.5 mL  in 100 mL
BASIL OIL (UNII: Z129UMU8LE) 1.45 mL  in 100 mL
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.6 mL  in 100 mL
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) 0.5 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90076-100-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:90076-100-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:90076-100-035000 mL in 1 BOTTLE; 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 - LibertyWare LLC (949700595)
Registrant - LibertyWare LLC (949700595)
Establishment
NameAddressID/FEIBusiness Operations
LibertyWare LLC949700595manufacture(90076-100)

Revised: 10/2020
Document Id: b1b28bd3-ef63-e330-e053-2a95a90a76e7
Set id: ac06c8d3-5e77-254c-e053-2a95a90a018e
Version: 3
Effective Time: 20201015
 
LibertyWare LLC