Flexitol ® Happy Little Bodies™ Eczema Relief Cream

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-866-478-3338

Websitewww.flexitol.comwww.flexitol.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

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

• eczema
• dermatitis
• rashes

Warnings

WARNINGS SECTION

For external use only

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days.

When using this product

OTC - WHEN USING SECTION

• do not get into eyes
• If contact occurs, rinse eyes thoroughly with water.
• wait 15 minutes. If redness or swelling occurs, discontinue use.

OTC - DO NOT USE SECTION

Do not use on broken skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

Store between 50– 86°F in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call Toll Free 1-866-478-3338

usainfo@flexitol.com
www.flexitol.com

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

DailyMed Dashboard NDC Coverage#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

• Flexitol Happy Little Bodies Eczema Relief
• oatmeal
• Aloe Vera Leaf
• Water
• Carbomer Interpolymer type A (Allyl Sucrose Crosslinked)
• Calendula Officinalis Flower
• Cetostearyl Alcohol
• Ceteth-20
• Dimethicone
• Edetate Disodium
• Glyceryl Monocaprylate
• Glyceryl Monostearate
• Glycerin
• Hydroxyacetophenone
• Isopropyl Myristate
• Mineral Oil
• Phenoxyethanol
• Trolamine
• SODIUM STEAROYL GLUTAMATE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.