PROTECTOR BRANDS HAND SANITIZER- ethyl alcohol gel

Protector Brands Hand Sanitizer by

Drug Labeling and Warnings

Protector Brands Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Raining Rose, Inc., Aire-Master of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 70%

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses
Hand Sanitizer to help reduce bacteria on the skin.
Recommended for repeated use.

WARNINGS

Warnings For external use only
Flammable, keep away from fire or flame
Do not use in eyes. In case of eye contact flush
thoroughly with water and seek medical attention.

Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours.

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

DOSAGE & ADMINISTRATION

Directions
Dispense an adequate amount in your palm to cover all surfaces of hands completely.

Rub hands together until dry. Does not require rinsing.

OTHER SAFETY INFORMATION

Other Information
Do not store above 100°F.
May discolor some fabrics.

INACTIVE INGREDIENT

Inactive Ingredients: Water (Aqua), Isopropyl Alcohol, Orange Oil, Acrylates/C10-30 Akyl Acrylate Crosspolymer, Glycerin, Aloe Barbadensis Leaf Juice, Panthenol, Aminomethyl Propanol.

Principal Display Package

Protector​TM​

HAND

SANITIZER

made with aloe vera

and 70% ethyl alcohol

EFFECTIVE

+

MOISTURIZING

2 FL OZ. (59 ml)

Manufactured for: Protector Brands

100 30th Street Drive SE, Cedar Rapids, IA 52403

888-301-4820| www.protectorbrands.com

L341477

Kills 99.99% of germs in 15 Seconds.

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INGREDIENTS AND APPEARANCE

PROTECTOR BRANDS HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-2001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ORANGE OIL (UNII: AKN3KSD11B)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-2001-1	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/01/2020

Labeler - Raining Rose, Inc. (083819404)

Registrant - Raining Rose, Inc. (083819404)

Establishment
Name	Address	ID/FEI	Business Operations
Aire-Master of America, Inc.		057897381	manufacture(65692-2001)