BUTTIEZZZ INTENSE- zinc oxide spray

Buttiezzz Intense by

Drug Labeling and Warnings

Buttiezzz Intense 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

Zinc Oxide 10%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash

Protect chafed skin due to diaper rash and helps seal out wetness

Warning

For external use only

Avoid contact with eyes

Stop use and contact a Doctor if

Condition worsens

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

Not to be applied over deep or 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

Change wet or soiled diapers promptly

Shake well before use. Make sure the thin is clean and dry before use. Use a sweeping movement to spray on the cream in a thin and uniform layer on the buttocks

Buttiezzz Intense is more effective when you apply a single thin layer. Use a spraying distance approximately 2 to 3 inches. It is not necessary to rub the cream. Apply Butiezzz Intense liberally as often as necessary or at every diaper change

Other Information

Store at room temperature bellow 77º F

Inactive Ingredients

Water(aqua)

Coco-Caprilate/Caprate

Glycerin

Alkyl-Alcohols

Alkyl Glucoside

Propilene Glycol

Cocoglycerides

Caprylyl glycol

Capryl Hydroxamic acid

Chamomilla Recutita(Matricaria)Flower Extract

Calendula Officinalis Flower Extract

Silica

Oleic Acid

Principle Display Panel.50ml Bottle Spray carton

INGREDIENTS AND APPEARANCE

BUTTIEZZZ INTENSE 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70359-4102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
OLEIC ACID (UNII: 2UMI9U37CP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHAMOMILE (UNII: FGL3685T2X)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLYCERIN (UNII: PDC6A3C0OX)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70359-4102-1	1 in 1 CARTON	01/20/2016
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	01/20/2016

Labeler - Fortunique B.V. (407788616)

Registrant - Fortunique B.V. (407788616)

Establishment
Name	Address	ID/FEI	Business Operations
Fortunique B.V.		407788616	manufacture(70359-4102)