POXIEZZZ- menthol, zinc oxide spray

Poxiezzz by

Drug Labeling and Warnings

Poxiezzz by is a Otc medication manufactured, distributed, or labeled by Fortunique B.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Menthol 1%

Zinc Oxide 4%

Purpose

Topical Analgesic

Skin Protectant

Uses

For the temporary relief of pain and itching associated with minor skin irritations

Protects chafed skin

Warning

For external use only

When using this product

Avoid contact with eyes

Stop use and contact a Doctor if

Condition worsens .

Symptoms last more than 7 days or clear up and occur within a few days.

Not to be applied over deep a puncture wounds, infection or lacerations

Keep out of reach of children

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

Directions

Not suitable for children under 2 years of age. Adults and children 2 years of age and older: Apply to affected area no more than 2 to 3 times daily. Shake well before use. Make sure the skin is clean and dry before spraying. Use a sweeping movement to spray-on the cream in a thin and uniform layer directly onto the affected skin. Use a spraying distance of approximately 2 to 3 inches. It is not necessary to rub the cream. When the skin is very sensitive, it is advised not to touch the skin too frequently.

Other information

Store at room temperature bellow 77º F

Inactive Ingredients

Water (aqua)

Coco-Caprylate/Caprate

Glycerin

Cetearyl Alcohol

Cetearyl Glucoside

Alky-Alcohols

Alkyl Glucoside

Cocoglycerides

Caprylylglycol

Caprylhydroxamic Acid

Silica

Oleic Acid

Principle Display Panel.Bottle Spray 50 ml

INGREDIENTS AND APPEARANCE

POXIEZZZ 
menthol, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70359-4106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
OLEIC ACID (UNII: 2UMI9U37CP)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
C14-22 ALCOHOLS (UNII: B1K89384RJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70359-4106-1	1 in 1 CARTON	01/21/2016
1		50 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/21/2016

Labeler - Fortunique B.V. (407788616)

Registrant - Fortunique B.V. (407788616)

Establishment
Name	Address	ID/FEI	Business Operations
Fortunique B.V.		407788616	manufacture(70359-4106)