JOSIE MARAN OTC ECZEMA BODY BUTTER -VANILLA AND CHAMOMILE- colloidal oatmeal 0.8% cream

JOSIE MARAN OTC ECZEMA BODY BUTTER -Vanilla and Chamomile by

Drug Labeling and Warnings

JOSIE MARAN OTC ECZEMA BODY BUTTER -Vanilla and Chamomile by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredient
Colloidal Oatmeal 0.8%

PURPOSE

Purpose

Skin protectant

INDICATIONS & USAGE

Uses
temporarily protects and helps relieve minor skin irritation and itching due to eczema

WARNINGS

Warnings

For external use only.

When using this product
do not get into eyes.

Stop use and ask a doctor if
condition worsens
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 right away

DOSAGE & ADMINISTRATION

Directions apply as needed.

INACTIVE INGREDIENT

Inactive Ingredients: Aloe Barbadensis Leaf Juice**, Caprylic/Capric Triglyceride**, Argania Spinosa
Kernel Oil**, Butyrospermum Parkii (Shea) Butter**, Glyceryl Stearate**, Stearyl Alcohol**, Fragrance**,
Glycerin**, Alpha-Glucan Oligosaccharide**, Diisopropyl Adipate, Glyceryl Behenate**, Sodium Stearoyl
Glutamate**, Squalane**, Water/Aqua/Eau**, Bisabolol**, Octyldodecyl PCA**, Xymenynic Acid, Citric
Acid**, Ethylhexylglycerin, Phenoxyethanol.
*ORGANIC **NATURALLY DERIVED

OTHER SAFETY INFORMATION

Other information
Store at room temperature.

QUESTIONS

Questions or comments?Call us at (888) 215-8733
or visit us at www.josiemaran.com Monday to Friday 6am-6pm PST

Product Package

JOSIE MARAN

ARGAN APOTHECARY

INTENSIVE DAILY REPAIR BODY BUTTER
Eczema Relief with Argan Oil + Colloidal Oatmeal

Vanilla and Chamomile

Net Wt. 170 g 6 oz.

Dist. by Josie Maran Cosmetics, LLC
Hollywood, CA 90038
josiemaran.com

@josiemaran

Carton Label

Jar Label

res

INGREDIENTS AND APPEARANCE

JOSIE MARAN OTC ECZEMA BODY BUTTER -VANILLA AND CHAMOMILE 
colloidal oatmeal 0.8% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-164
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	8.0 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ARGAN OIL (UNII: 4V59G5UW9X)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SQUALANE (UNII: GW89575KF9)
WATER (UNII: 059QF0KO0R)
LEVOMENOL (UNII: 24WE03BX2T)
OCTYLDODECYL PCA (UNII: E25TY46YTD)
XYMENYNIC ACID (UNII: IA0Z48P13W)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-164-50	1 in 1 CARTON	07/08/2022
1		170 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/08/2022

Labeler - Bentley Laboratories, LLC (068351753)