FDA Label for Medibalm
View Indications, Usage & Precautions
Medibalm Product Label
The following document was submitted to the FDA by the labeler of this product Balmrx, Llc. 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 1.0%...........Anti-Itch
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"
* Please review the disclaimer below.
