Label: DIAPER RASH CREAM- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72381-101-01 - Packager: Hamilton Therapeutics, Inc
- 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 November 30, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients Helianthus Annuus (Sunflower) Seed Oil, Beeswax (Cera Alba), Polyhydroxystearic Acid, Butyrospermum Parkii (Shea Butter), Calophyllum Tacamahaca (Tamanu) Seed Oil, Olea Europaea (Olive) Fruit Oil, Cocos Nucifera (Coconut) Oil, Honey, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract,Tocopherol, Squalene, Sterols, Monoglycerides.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIAPER RASH CREAM
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72381-101 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 mL Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SHEA BUTTER (UNII: K49155WL9Y) COCONUT OIL (UNII: Q9L0O73W7L) CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE) OLIVE OIL (UNII: 6UYK2W1W1E) HONEY (UNII: Y9H1V576FH) LEMON PEEL (UNII: 72O054U628) SAGE (UNII: 065C5D077J) SQUALENE (UNII: 7QWM220FJH) WHITE WAX (UNII: 7G1J5DA97F) CHAMOMILE (UNII: FGL3685T2X) CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83) CITRUS SINENSIS FLOWER (UNII: H02N5LQ5F6) THYME (UNII: CW657OBU4N) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72381-101-01 98 mL in 1 TUBE; Type 0: Not a Combination Product 06/07/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/07/2018 Labeler - Hamilton Therapeutics, Inc (099419360)