HAND SANITIZER- alcohol spray

Hand sanitizer by

Drug Labeling and Warnings

Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Physicians Formula. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl alcohol 80% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame.

For external use only - do not use on damaged or broken skin

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughyl with water.

Stop use and ask a doctor

if irritation or rash occurs and lasts.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Other information

Store below 110 F (43 C)

May discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua/Eau), Fragrance (Parfum), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Portulaca Oleracea Extract, Aloe Barbadensis Leaf Juice, Potassium Sorbate, Sodium Benzoate, Citric Acid, Butylene Glycol, Red 40 (CI 16035)

Directions

Spray enough product on hands to cover completely

Rub hands together until thoroughly dry

Children under 6 years of age should be supervised when using this product

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31645-216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PORTULACA OLERACEA LEAF (UNII: 9JW9D9JGHZ)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31645-216-01	26 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/10/2020

Labeler - Physicians Formula (021261805)