HAND SANITIZER- alcohol spray 
ACT Labs

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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HAND SANITIZER

This is a hand sanitizer manufactured according to the Hand Sanitizer final monograph.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

Do not use

When 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.

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

60 mL NDC: 75664-1120-1 60 ML SPRAY

250 mL NDC: 75664-1120-2

250 ML SPRAY

HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75664-1120
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
TEA TREE OIL (UNII: VIF565UC2G) 0.0001 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0) 0.0001 mL  in 100 mL
TURMERIC OIL (UNII: 6KGS8SP16U) 0.0001 mL  in 100 mL
LEMON OIL (UNII: I9GRO824LL) 0.0001 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0001 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75664-1120-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
2NDC:75664-1120-2250 mL in 1 BOTTLE, SPRAY; 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 - ACT Labs (078833578)
Registrant - ACT Labs (078833578)
Establishment
NameAddressID/FEIBusiness Operations
ACT Labs078833578manufacture(75664-1120)

Revised: 8/2020
Document Id: ad6ac5a5-1c34-2487-e053-2995a90ac647
Set id: ad6aa48f-135d-2617-e053-2995a90a517b
Version: 1
Effective Time: 20200821
 
ACT Labs