FDA Label for Bioelements Immediate Comfort

View Indications, Usage & Precautions

Bioelements Immediate Comfort Product Label

The following document was submitted to the FDA by the labeler of this product Bioelements, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient Purpose

Hydrocortisone Acetate 1% Anti-itch lotion


Otc - 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.


Otc - Keep Out Of Reach Of Children



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


Indications & Usage



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



Warnings

For external use only

When using this product avoid contact with the eyes.


Dosage & Administration



Directions

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


Inactive Ingredient



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)


Package Label.Principal Display Panel



Bioelements PROFESSIONAL-USE-ONLY

Immediate comfort

1% Hydrocortisone Acetate Lotion

88 ml/ 3 Fl Oz.


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