ARCTIVA ECZEMA CREAM- eczema cream cream

Arctiva Eczema Cream by

Drug Labeling and Warnings

Arctiva Eczema Cream by is a Otc medication manufactured, distributed, or labeled by Tropical. Enterprises International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Colloidal oatmeal 1%......

PURPOSE

Purpose... Skin protectant

INDICATIONS & USAGE

Uses: Temporarily protects and helps relieve minor skin irritations, redness, dryness, cracking and itching

due to eczema and dermatitis.

WARNINGS

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

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

a Poison. Control Center immediately.

DOSAGE & ADMINISTRATION

Directions Apply twice daily or as needed.
For best results apply after cleansing.

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

Other Information: Store at room temperature.

QUESTIONS

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

SPL UNCLASSIFIED SECTION

THE ARCTIVA GUARANTEE

Arctiva relief goes beyond the surface. If for any reason you're

not completely satisfied contact us within 60 days of your purchase

for a full refund.

Distributed by:

Arctiva Wellness, LLC

30600 Aurora Rd.

Suite 180

Salon, OH 44139

Made in U.S.A

arctivaskin.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARCTIVA ECZEMA CREAM 
eczema cream cream

Product 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 - Epic Laboratories, LLC (119307904)