MCCLAINS EXTRA STRENGTH AND MOISTURE HAND SANITIZER ORIGINAL- isopropyl alcohol liquid 
McClain's Health 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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Hand sanitizer

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with CDC recommendations:

  1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Sterile distilled water or boiled cold water.

Formulation:

Formulation

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Active Ingredients

Purpose

Antiseptic, Hand Sanitizer

Purpose

Use

Hand Sanitizer to help reduce bacteria on the skin.

Usage

Warnings

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

Warning

Do not use

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.

When Using

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

Stop Use

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

Keep Out Of Reach Of Children

Directions

Instructions

Other information

Storage

Inactive ingredients

USP Purified Water, Organic Aloe Leaf Juice, Phenoxyethanol, Glycerin, Withc Hazel Water, Alcohol, Carbomer, Triethanolamine, Tetrasodium Glutamate Diacetate, Essential Oils.

Inactive Ingredients

Package Label - Principal Display Panel

60 ml NDC: 81150-001-01

Principal Display

MCCLAINS EXTRA STRENGTH AND MOISTURE HAND SANITIZER ORIGINAL 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81150-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LEMON OIL (UNII: I9GRO824LL)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
CINNAMON OIL (UNII: E5GY4I6YCZ)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX) 1.25 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 23 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
WITCH HAZEL (UNII: 101I4J0U34) 0.25 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)  
CLOVE OIL (UNII: 578389D6D0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.25 mL  in 100 mL
ALCOHOL (UNII: 3K9958V90M) 0.25 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81150-001-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/19/2020
Labeler - McClain's Health LLC (131111024)

Revised: 11/2020
Document Id: b4479e85-eed6-8577-e053-2a95a90ad3d8
Set id: b4479e85-eee4-8577-e053-2a95a90ad3d8
Version: 1
Effective Time: 20201119
 
McClain's Health LLC