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Bioelements Immediate Comfort

Generic Name: hydrocortisone acetate
Dosage Form: topical lotion

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.

BIOELEMENTS  IMMEDIATE COMFORT
hydrocortisone acetate lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49825-126
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 0.088 mL  in 88 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description
1 NDC:49825-126-01 88 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 08/23/2012
Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
Name Address ID/FEI Operations
Dhaliwal Labs 016754201 manufacture(49825-126)
Revised: 08/2012
 
Bioelements, Inc.



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