ATTITUDE DIAPER CREAM ZINC UNSCENTED- zinc oxide stick

Attitude Diaper Cream Zinc Unscented by

Drug Labeling and Warnings

Attitude Diaper Cream Zinc Unscented by is a Otc medication manufactured, distributed, or labeled by 9055-7588 Quebec Inc. (Attitude), 9055-7588 Quebec Inc dba Attitude. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Zinc oxide (15%)

PURPOSE

Skin protectant - Diaper rash treatment

INDICATIONS & USAGE

Helps prevent diaper rash.

Protects chafed irritated skin due to diaper rash.

Helps protect from wetness that causes diaper rash.

Temporarily protects and helps relieve minor skin irritation due to diaper rash.

Helps treat/heal diaper rash.

WARNINGS

Allergens: almond

For external use only.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult a doctor if symptoms worsen or last for more than 7 days.

Keep out of reach of children. If swallowed, call a poison control centre or get edical help right away.

DOSAGE & ADMINISTRATION

Change wet and soiled diapers promptly, cleanser the diaper area, and allow to dry. Push on the bottom to release the product. Heat the product for a few seconds on your hands and apply on baby's bottom. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. If necessary, after use, wipe off the excess on the tube contour before closing it.

STORAGE AND HANDLING

Store at temperatures below 90 F (32 C).

INACTIVE INGREDIENT

Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, Vitis Vinifera (Grape) Seed Oil, C10-18 Triglycerides, Behenyl Behenate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Vaccinium Myrtillus (Blueberry) Leaf Extract.

PRINCIPAL DISPLAY PANEL

ATTITUDETM

natural care

baby leavesTM

diaper cream - zinc

protects & nourishes

Unscented

EWG VerifiedTM

Vegan

Stick 30g /1 oz.

NPN 80119243

dermatologically tested

plastic free

INGREDIENTS AND APPEARANCE

ATTITUDE DIAPER CREAM ZINC UNSCENTED 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61649-260
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
CANDELILLA WAX (UNII: WL0328HX19)
GRAPE SEED OIL (UNII: 930MLC8XGG)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
ALMOND OIL (UNII: 66YXD4DKO9)
COCONUT OIL (UNII: Q9L0O73W7L)
CASTOR OIL (UNII: D5340Y2I9G)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
VACCINIUM MYRTILLUS LEAF (UNII: Y4U591OU70)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61649-260-01	30 g in 1 TUBE; Type 0: Not a Combination Product	07/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/24/2023

Labeler - 9055-7588 Quebec Inc. (Attitude) (201137051)

Establishment
Name	Address	ID/FEI	Business Operations
9055-7588 Quebec Inc dba Attitude		204307099	analysis(61649-260) , label(61649-260) , manufacture(61649-260) , pack(61649-260)