Bioelements
FDA Label NDC 49825-126

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bioelements, Inc. for the product Bioelements (NDC 49825-126). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Image Of Bottle Art (Bottle)

Image Of Bottle Art (Bottle)

Bioelements PROFESSIONAL-USE-ONLY

Immediate comfort

1% Hydrocortisone Acetate Lotion

88 ml/ 3 Fl Oz.

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