Otc - Active Ingredient
ACTIVE INGREDIENT PURPOSE
Hydrocortisone 1.0%...........Anti-Itch
Medibalm Ointment
FDA Label NDC 85529-204
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Balmrx, Llc for the product Medibalm (NDC 85529-204). 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, indications & usage, warnings, otc - stop use, otc - do not use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
ACTIVE INGREDIENT PURPOSE
Hydrocortisone 1.0%...........Anti-Itch
Indications & Usage
USES
For the temporary relief of itching
associated with minor skin
irritations and rashes due to:
- Eczema
- Cosmetics
- Psoriasis
- Seborrheic Dermatitis
- Other uses of this product should
be only under the advice and
supervision of a physician.
Warnings
For external use only. Avoid contact with eyes.
Otc - Stop Use
and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor.
Otc - Do Not Use
for the treatment of diaper rash. Consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Dosage & Administration
D IRECTIONS
- Adults and children 2 years of
- Children under 2 years of age:
age and older: apply to affected
area not more than 3 to 4 times
daily for up to 7 days.
do not use, consult a physician
Inactive Ingredient
INACTIVE INGREDIENTS
coconut oil, shea butter, cera
microcristallina, tocopherol,
phenoxyethanol
Storage And Handling
OTHER INFORMATION
Store at 59-80 F (15-30 C).
Protect from freezing.
Recent Major Changes
- Removed "Warnings and Precautions section"
- Added "OTC - Purpose section" - "ACTIVE INGREDIENT PURPOSE Hydrocortisone 1.0%...........Anti-Itch"
- Added "Warnings section" - "For external use only. Avoid contact with eyes."
- Added "OTC - Stop use section" - "and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor."
- Added "OTC - Do not use section" - "for the treatment of diaper rash. Consult a doctor."
- Added "OTC - Keep out of reach of Children section"
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