Label: ATTITUDE DIAPER CREAM ZINC UNSCENTED- zinc oxide stick
- NDC Code(s): 61649-260-01
- Packager: 9055-7588 Quebec Inc. (Attitude)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 10, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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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
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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
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INGREDIENTS AND APPEARANCE
ATTITUDE DIAPER CREAM ZINC UNSCENTED
zinc oxide stickProduct 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 final 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)
