MCCLAINS EXTRA STRENGTH AND MOISTURE HAND SANITIZER ORIGINAL- isopropyl alcohol liquid

McClains Extra Strength And Moisture Hand Sanitizer Original by

Drug Labeling and Warnings

McClains Extra Strength And Moisture Hand Sanitizer Original by is a Otc medication manufactured, distributed, or labeled by McClain's Health LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

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

Do not use

• keep out of reach of children
• do not use in or near the eyes

WHEN USING

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

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

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

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

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

Package Label - Principal Display Panel

60 ml NDC: 81150-001-01

INGREDIENTS AND APPEARANCE

MCCLAINS EXTRA STRENGTH AND MOISTURE HAND SANITIZER ORIGINAL 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81150-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81150-001-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/19/2020

Labeler - McClain's Health LLC (131111024)