HYDROCORTISONE- drs. hydrocortisone cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by OL PHARMA TECH,LLC, OL PHARMA TECH,LLC (Drs. pharmacy). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrocortisone, USP 1%

PURPOSE

Anti-itch

USES

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

eczema

insect bites

poison ivy

poison oak

poison ...

WARNINGS

For external use only

DO NOT USE

for external feminine itching if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.

WHEN USING THIS PRODUCT

avoid contact with the eyes

do not begin the use of any other hydrocortisone product unless directed by a doctor

for external anal itching:

do not use more than directed unless directed by a doctor

do not put this product into the rectum by using fingers or any mechanical device or applicator

STOP USE AND ASK YOUR DOCTOR IF

symptoms last for more than 7 days

the condition gets worse

symptoms clear up and occur again in a few days

rectal bleeding occurs, consult doctor promptly

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.

DIRECTIONS

• Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• Children under 2 years of age: do not use, consult a doctor
• For external anal itching
• Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

OTHER INFORMATION

• Store at room temperature 59°-86°F (15°-30°C).
• Protect from freezing.
• Before using any medication, read all label directions. Keep carton, it contains important information.

INACTIVE INGREDIENTS

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil , propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

PRINCIPAL DISPLAY PANEL

original strenghth

fast itch relief cream

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
drs. hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80489-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETEARETH-12 (UNII: 7V4MR24V5P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MINERAL OIL (UNII: T5L8T28FGP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80489-001-01	1 in 1 CARTON	01/01/2021
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 80489-001-02	1 in 1 CARTON	01/01/2021
2		49.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	01/01/2021

Labeler - OL PHARMA TECH,LLC (021170377)

Registrant - OL PHARMA TECH,LLC (021170377)

Establishment
Name	Address	ID/FEI	Business Operations
OL PHARMA TECH,LLC (Drs. pharmacy)		021170377	manufacture(80489-001)