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Immediate Comfort Bioelements

Dosage form: lotion
Ingredients: HYDROCORTISONE ACETATE 1g in 88mL
Labeler: Bioelements, Inc.
NDC Code: 49825-134

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

Active Ingredient Purpose

Hydrocortisone Acetate 1% Anti-itch lotion

Uses

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

Other uses of this product should be only under the advice and supervision of a doctor.

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

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.

Directions

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

Inactive ingredients

Butylene Glycol, C12-15 Alkyl Benzoate, Carbomer, Glyceryl Stearate, Helianthuus annus (sunflower) Seed Oil, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Ploysorbate 80, Sodium Hydroxide, Sorbitol, Tocopheryl Acetate, Water (Aqua, Eau)

Bioelements PROFESSIONAL-USE-ONLY

Immediate comfort

1% Hydrocortisone Acetate Lotion

88 ml/ 3 Fl Oz.

IMMEDIATE COMFORT  BIOELEMENTS
hydrocortisone acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-134
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE1 g  in 88 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL 
ALKYL (C12-15) BENZOATE 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
GLYCERYL MONOSTEARATE 
SUNFLOWER OIL 
METHYLISOTHIAZOLINONE 
PEG-100 STEARATE 
PHENOXYETHANOL 
POLYSORBATE 80 
SODIUM HYDROXIDE 
SORBITOL 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:49825-134-0188 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/23/2012
Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
NameAddressID/FEIOperations
Dhaliwal Labs016754201manufacture(49825-134)

Revised: 01/2017
 
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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