Label: ARCTIVA PSORIASIS CREAM- psoriasis cream cream
- NDC Code(s): 58418-822-40, 58418-822-44, 58418-822-45, 58418-822-99
- Packager: Tropical Enterprises International, Inc.
- Category: HUMAN OTC DRUG LABEL
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 August 6, 2023
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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, Glyceryl Stearate,
Candelilla/Jojoba/Rice Bran Polyglyceryl- 3
Esters, Sodium Hydroxide, Sodium stearoyl
lactylate, Cetearyl Alcohol, Phenoxyethanol,
Pentylene Glycol, Hydrosurf (Glycolipids),
Hydroxyethylcellulose, Ethylhexyglycerin,
Sodium Ascorbyl Phosphate, Vitamin B3
(Niacinamide), Vitamin A (Retinyl Palmitate),
Tocopherol, Soybean Oil.
- STORAGE AND HANDLING
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- 130ml
- 40ml label and outer carton
-
INGREDIENTS AND APPEARANCE
ARCTIVA PSORIASIS CREAM
psoriasis cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58418-822 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2.6 g in 130 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) NIACINAMIDE (UNII: 25X51I8RD4) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) CANDELILLA WAX (UNII: WL0328HX19) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) RICE BRAN (UNII: R60QEP13IC) LIPID A 504 (UNII: Q2VF73396U) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) 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:58418-822-99 1 in 1 CARTON 02/01/2023 1 NDC:58418-822-45 130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:58418-822-44 1 in 1 CARTON 10/02/2023 2 NDC:58418-822-40 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 final M032 02/01/2023 Labeler - Tropical Enterprises International, Inc. (091986179)