INSTANT HAND SANITIZER- ethyl alcohol gel

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by PrimeCare + Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

75% Ethyl Alcohol

PURPOSE

Purpose
Antiseptic

INDICATIONS & USAGE

Uses:

• For hand washing to decrease bacteria/microorganisms on the skin that can cause diseases.
• Recommended for repeated use.

WARNINGS

Warnings:   

◊ For external use only. Avoid contact with broken skin.                                                                                                                                   
◊ Flammable, keep away from heat, flame or fire.                                                                                                                                                                                                                                               ◊ Do not use this product,in or near the eyes.
◊ If eye contact, immediately rinse thoroughly with a lot of water.

STOP USE

• Stop use and ask a doctor if irritation, redness, or rash develops and persists for more than 3 days.
• If swallowed, get medical help or contact a Poison Control Center right away.
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. Do not inhale or ingest.

DOSAGE & ADMINISTRATION

Directions:

◊ Wet hands thoroughly with product                                                                                                                                                                         ◊ Rub hands together covering all surfaces until dry quickly without wiping                                                                                                             ◊ Not recommended for infants                                                                                                                                                                                   ◊ Use in children under 6 years of age must be supervised                                                                                                                                  Other Information:
◊ Do not store above 105 F or 39 C
◊ May discolor some fabrics, wood finishes and plastics

INACTIVE INGREDIENT

Inactive Ingredients: 

Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Hamamelis Virginiana (witchhazel) Leaf Extract, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER  
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69410-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69410-0001-8	240 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/26/2014

Labeler - PrimeCare + Inc. (038816798)