FDA Label for Flexitol Happy Little Bodies Eczema Relief

View Indications, Usage & Precautions

Flexitol Happy Little Bodies Eczema Relief Product Label

The following document was submitted to the FDA by the labeler of this product Lacorium Health Usa Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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.

Otc - Do Not Use



Do not use on broken skin


Otc - 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.


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

[email protected]
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)


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