Label: ARCTIVA ECZEMA CREAM- eczema cream cream
- NDC Code(s): 58418-821-40, 58418-821-44, 58418-821-45, 58418-821-99
- Packager: Tropical. Enterprises International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 10, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
Inactive Ingredients: Water, Cetyl Alcohol, Stearyl Alcohol,
Candelila/Jojoba/Rice Bran Polyglyceryl-3 esters, Glyceryl Stearate,
Sodium Hydroxide, Sodium stearoyl lactylate,Cetearyl Alcohol, Phenoxyethanol, Pentylene Glycol,Hydrosuf (Glycolipids), Glycolic Acid, Vitamin B3 (Niacinamide), Hydroxyethylcellulose, Ethylhexyglycerin,
Sodium Ascorbyl Phosphate, Vitamin A (Retinyl Palmitate), Tocopherol, Soybean Oil.
- STORAGE AND HANDLING
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- 130ml
- 40ml
-
INGREDIENTS AND APPEARANCE
ARCTIVA ECZEMA CREAM
eczema cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58418-821 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1 g in 130 mL Inactive Ingredients Ingredient Name Strength JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) NIACINAMIDE (UNII: 25X51I8RD4) HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) RICE BRAN (UNII: R60QEP13IC) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PHENOXYETHANOL (UNII: HIE492ZZ3T) PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCOLIC ACID (UNII: 0WT12SX38S) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CANDELILLA WAX (UNII: WL0328HX19) LIPID A 504 (UNII: Q2VF73396U) Product Characteristics Color white (lotion) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58418-821-99 1 in 1 CARTON 02/01/2023 1 NDC:58418-821-45 130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:58418-821-44 1 in 1 CARTON 10/02/2023 2 NDC:58418-821-40 40 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M032 02/01/2023 Labeler - Tropical. Enterprises International, Inc. (091986179)