ARCTIVA PSORIASIS CREAM- psoriasis cream cream 
Tropical Enterprises International, Inc.

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.

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Arctiva Psoriasis Cream

Active Ingredient
Salysilic Acid 2%.........

Purpose.... Psoriasis

Uses: Temporarily protects and helps relieve minor skin irritation and itching due to psoriasis.

Warnings

For external use only. When using this product: do not get into eyes.

Stop using and ask a doctor if: condition worsen, symptoms last more than

7 days or clear up and occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a

Poison Control Center immediately.

Directions Apply twice daily or as needed.

For best results apply after cleansing.

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.

Other Information: Store at room temperature.

Questions: 1-833-933-SKIN (7546)

THE ARCTIVA GUARANTEE

Arctiva relief goes beyond the surface. If for any reason

you're not completely satisfied contact us within 60days of your purchase for a

full refund.

Distributed by:

Arctiva Wellness, LLC

30600 Aurora Rd.

Suite 180

Solon, OH 44139

Made in U.S.A

arctivaskin.com

130ml

Psoriasis_130mL_labelPsoriasis_130mL-outercarton

40ml label and outer carton


Psoriasis_40mL_label


Psoriasis_40mL_outercarton

ARCTIVA PSORIASIS CREAM 
psoriasis cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-822
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.6 g  in 130 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (lotion) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58418-822-991 in 1 CARTON02/01/2023
1NDC:58418-822-45130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:58418-822-441 in 1 CARTON10/02/2023
2NDC:58418-822-4040 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03202/01/2023
Labeler - Tropical Enterprises International, Inc. (091986179)

Revised: 8/2023
Document Id: 024d6559-f7d0-f243-e063-6294a90a8cdc
Set id: eff6818f-82b3-5dda-e053-2995a90aaf58
Version: 2
Effective Time: 20230806
 
Tropical Enterprises International, Inc.