Immediate Comfort Bioelements

BIOELEMENTS IMMEDIATE COMFORT- hydrocortisone acetate 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.

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 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 Multilevel Packaging 1 NDC:49825-126-01 88 mL in 1 BOTTLE None

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.