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Bioelements

Bioelements, Inc.
Bioelements, Inc.

Immediate Comfort




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient Purpose

Hydrocortisone Acetate 1% Anti-itch lotion

Purpose

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.

Uses

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

Bioelements PROFESSIONAL-USE-ONLY

Immediate comfort

1% Hydrocortisone Acetate Lotion

88 ml/ 3 Fl Oz.

Bioelements

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 0.088 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 Marketing Start Date Marketing End Date
1 NDC:49825-126-01 88 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2012-08-23


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