MEDIBALM- hydrocortisone ointment

MediBalm by

Drug Labeling and Warnings

MediBalm by is a Otc medication manufactured, distributed, or labeled by BalmRx, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT PURPOSE
Hydrocortisone 1.0%...........Anti-Itch

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.

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.

DO NOT USE

for the treatment of diaper rash. Consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

D IRECTIONS

• Adults and children 2 years of

age and older: apply to affected
area not more than 3 to 4 times
daily for up to 7 days.

• Children under 2 years of age:

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDIBALM 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85529-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85529-204-01	1 in 1 BOX	04/21/2025
1		7 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/21/2025

Labeler - BalmRx, LLC (125365741)