DRS. HYDROCORTISONE ALOE VERA- hydrocortisone cream

Drs. Hydrocortisone Aloe Vera by

Drug Labeling and Warnings

Drs. Hydrocortisone Aloe Vera 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, Aloe vera leaf.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DRS. HYDROCORTISONE ALOE VERA 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80489-088
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80489-088-01	1 in 1 CARTON	01/01/2021
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 80489-088-02	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(80489-088)