FLEXITOL ECZEMA AND DERMATITIS- oatmeal cream

Flexitol Eczema and Dermatitis by

Drug Labeling and Warnings

Flexitol Eczema and Dermatitis by is a Otc medication manufactured, distributed, or labeled by LaCorium Health USA Inc, Ross Cosmetics Pty Ltd, Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Colloidal Oatmeal 5%

Purpose

Skin protectant

Uses

temporarily protects and relieves minor skin irritation and itching due to:

• eczema
• dermatitis
• rashes

Warnings

For external use only

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.

When using this product

• do not get into eyes
• If contact occurs, rinse eyes thoroughly with water.
• Do not use on broken skin.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply as needed to affected skin 2-3 times a day
• Smooth in gently
• The smallest effective dose should be used
• Patch test recommended on sensitive skin
• Suitable for use on children 2 years of age and older

Other Information

Store between 50-86°F in a dry place

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice powder, calendula officinalis flower extract, cetearyl alcohol, ceteth-20, dimethicone 100, edetate disodium, glycerin, glyceryl caprylate, glyceryl stearate, hydroxyacetophenone, isopropyl myristate, mineral oil light, phenoxyethanol, sodium benzoate, sodium stearoyl glutamate, triethanolamine, water

Questions or Comments?

Call Toll Free 1-877-687-2542

usainfo@flexitol.com
www.flexitol.com

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

NDC: 43251-9020-1

Flexitol®

ECZEMA
& DERMATITIS
CREAM

RASH RELIEF

RELIEVES RASH, IRRITATION,
ITCHING AND REDNESS

FREE FROM CORTISONE,
COAL AND PINE TAR

COLLOIDAL OATMEAL 5%
SKIN PROTECTANT CREAM

SUITABLE FOR
CHILDREN

Proud Supporter
eczema
association
australasia
eaa

Net Wt. 2.11 oz (60 g)

INGREDIENTS AND APPEARANCE

FLEXITOL ECZEMA AND DERMATITIS 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43251-9020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
oatmeal (UNII: 8PI54V663Y) (oatmeal - UNII:8PI54V663Y)	oatmeal	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Water (UNII: 059QF0KO0R)
Carbomer Interpolymer type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Ceteth-20 (UNII: I835H2IHHX)
Dimethicone (UNII: 92RU3N3Y1O)
Edetate Disodium (UNII: 7FLD91C86K)
Glyceryl Monocaprylate (UNII: TM2TZD4G4A)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Glycerin (UNII: PDC6A3C0OX)
Hydroxyacetophenone (UNII: G1L3HT4CMH)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Mineral Oil (UNII: T5L8T28FGP)
Phenoxyethanol (UNII: HIE492ZZ3T)
Trolamine (UNII: 9O3K93S3TK)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43251-9020-1	1 in 1 CARTON	01/10/2020
1		56 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43251-9020-2	1 g in 1 PACKET; Type 0: Not a Combination Product	01/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M016	01/10/2020

Labeler - LaCorium Health USA Inc (111254392)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	MANUFACTURE(43251-9020)