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Name:Bioelementsimmediate Comfort Hydrocortisone
Manufacturer:Bioelements, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Immediate Comfort 1% Hydrocortisone Lotion

BIOELEMENTS IMMEDIATE COMFORT HYDROCORTISONE - hydrocortisone lotion 
Bioelements, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Immediate Comfort 1% Hydrocortisone Lotion


Active Ingredients                                         Purpose
Hydrocortisone 1%                                       Anti-Itch Lotion

for the temporary relief of itching associated with minor skin irritations and rashes due to eczema, detergents, cosmetics, jewelry, dermatitis, psoriasis.

-Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

-For external use only

-When using this product avoid contact with the eyes
-Stop use and ask a doctor if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days


-apply to affected areas no more than 3 to 4 times daily.

Inactive Ingredients: Water (Aqua) (Eau), Helianthus Annuus (Sunflower) Seed Oil, C12-15 Alkyl Benzoate, Butylene Glycol, Sorbitol, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Carbomer, Polysorbate 80, Sodium Hydroxide, Methylisothiazolinone



image of back label

Bioelements

Immediate Comfort - 1% Hydrocortisone Lotion

88 mL / 3 Fl. Oz.



label of primary label


BIOELEMENTS  IMMEDIATE COMFORT HYDROCORTISONE
hydrocortisone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-119
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
HELIANTHUS ANNUUS FLOWER  
ALKYL (C12-15) BENZOATE  
BUTYLENE GLYCOL  
SORBITOL  
GLYCERYL MONOSTEARATE  
PEG-100 STEARATE  
POLYSORBATE 80  
SODIUM HYDROXIDE  
METHYLISOTHIAZOLINONE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49825-119-02 1 JAR ( JAR) in 1 BOX contains a JAR (49825-119-01)
1 NDC:49825-119-01 88 mL in 1 JAR This package is contained within the BOX (49825-119-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 08/19/2010

Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
Name Address ID/FEI Operations
Chemolee Lab Corporation 809982754 manufacture

Revised: 03/2011 Bioelements, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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