INTENSIVE DAILY REPAIR BODY BUTTER- colloidal oatmeal cream

Intensive Daily Repair Body Butter by

Drug Labeling and Warnings

Intensive Daily Repair Body Butter 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

HOW TO USE: Apply twice daily or as needed to soothe irritation and itching due to eczema.

INACTIVE INGREDIENT

Inactive Ingredients: Aloe Barbadensis Leaf Juice**, Caprylic/Capric Triglyceride**, Butyrospermum
Parkii (Shea) Butter**, Argania Spinosa Kernel Oil*, Glyceryl Stearate**, Stearyl Alcohol**, 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

Product Package

JOSIE MARAN

ARGAN APOTHECARY

Intensive Daily Repair Body Butter
Eczema Relief with Argan Oil + Colloidal Oatmeal

10mL | 0.34 fl. oz.

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

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INGREDIENTS AND APPEARANCE

INTENSIVE DAILY REPAIR BODY BUTTER 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-162
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SHEA BUTTER (UNII: K49155WL9Y)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
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 BEHENATE (UNII: BZM9WE5P6F)
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: 54111-162-50	10 mL in 1 PACKET; Type 0: Not a Combination Product	02/21/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/21/2022

Labeler - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(54111-162)