BIOELEMENTS IMMEDIATE COMFORT HYDROCORTISONE - hydrocortisone lotion 
Bioelements, Inc.

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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

Bioelements

Immediate Comfort - 1% Hydrocortisone Lotion

88 mL / 3 Fl. Oz.

BIOELEMENTS  IMMEDIATE COMFORT HYDROCORTISONE hydrocortisone   lotion

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 49825-119-02 1 JAR In 1 BOX contains a JAR (49825-119-01) 1 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: 03/2011Bioelements, Inc.