Bioelements Immediate Comfort Hydrocortisone

Dosage form: lotion
Ingredients: HYDROCORTISONE 1mL in 100mL
Labeler: Bioelements, Inc.
NDC Code: 49825-119

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.

Immediate Comfort Hydrocortisone cream

Active Ingredients                               purpose

Hydrocortisone Acetate 1%               Anti-itch lotion


Uses

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

Other uses of the product should be only under the advice of a doctor


Keep out of reach of children.


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.

Warnings

For external use only

When using this product avoid contact with the eyes.

If swallowed get medical help or contact a poison control center right away.

Directions

Apply to affected areas no more than 3 to 4 times daily.

Inactive Ingredients

Water (Aqua)(Eau), Helianthus Annus (Sunflower) seed oil, C12-15 Alkyl Benzoate, Butylene Glycol, Sorbitol, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Carbomer, Polysorbate 80, Sodium Hydroxide, Methylisothiazolinone





Biolelements
Proffessional-Use-Only


Immediate comfort

1% Hydrocortisone Lotion

88 ml/ 3 Fl. Oz.




BIOELEMENTS  IMMEDIATE COMFORT HYDROCORTISONE
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-119
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HELIANTHUS ANNUUS FLOWERING TOP 
ALKYL (C12-15) BENZOATE 
BUTYLENE GLYCOL 
SORBITOL 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
POLYSORBATE 80 
SODIUM HYDROXIDE 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage Description
1NDC:49825-119-021 JAR (JAR) in 1 BOX
1NDC:49825-119-0188 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/19/2010
Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
NameAddressID/FEIOperations
Chemolee Lab Corporation809982754manufacture

Revised: 01/2012
 
Bioelements, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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