FLEXITOL HAPPY LITTLE BODIES ECZEMA RELIEF- oatmeal cream

Flexitol Happy Little Bodies Eczema Relief by

Drug Labeling and Warnings

Flexitol Happy Little Bodies Eczema Relief by is a Otc medication manufactured, distributed, or labeled by LaCorium Health USA Inc, Bentley Laboratories, LLC, Ross Labpratories Pty Ltd. 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.
• wait 15 minutes. If redness or swelling occurs, discontinue use.

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

Other Information

Store between 50– 86°F in a dry place

Inactive ingredients

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

Questions or Comments?

Call Toll Free 1-866-478-3338

usainfo@flexitol.com
www.flexitol.com

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

NDC: 43251-4927-1

Flexitol®

happy
little bodies™

ECZEMA
RELIEF
CREAM

SOOTHES RASHES
& FLARE-UPS

Gentle Formula
Skin Protectant Cream with
colloidal oatmeal 5%

Proud Supporter
eczema
association
australasia
eaa

Net Wt. 2 oz (56 g)

INGREDIENTS AND APPEARANCE

FLEXITOL HAPPY LITTLE BODIES ECZEMA RELIEF 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43251-4927
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: 43251-4927-1	1 in 1 CARTON	01/02/2022
1		56 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43251-4927-2	1 g in 1 PACKET; Type 0: Not a Combination Product	01/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M016	11/29/2021

Labeler - LaCorium Health USA Inc (111254392)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	MANUFACTURE(43251-4927)