HYDROCORTISONE- hydrocortisone liquid

HYDROCORTISONE by

Drug Labeling and Warnings

HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                            Purpose

Hydrocortisone 1%...................................External analgesic

PURPOSE

Active ingredient                            Purpose

Hydrocortisone 1%...................................External analgesic

Uses Temporarily relieves itching associated with minor skin
irritation and rashes due to saborrheic dermatitis and psoriasis.
Other uses of this product should be only used under the advice
and supervision of a doctor.

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.

INDICATIONS & USAGE

Directions 

- adults and children 2 years and older: apply to affected areas one to four times daily

- children under 2 years of age, do not use, consult a doctor

WARNINGS

Warnings

For external use only.

When using this product

- do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.

Stop use of this product and do not begin use of any other hydrocortisone product if

- condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, unless you have consulted a doctor.

Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

Flammable, Keep away from fire or flame.

DOSAGE & ADMINISTRATION

Directions

- adults and children 2 years and older: apply to affected areas one to four times daily

- children under 2 years of age, do not use, consult a doctor

INACTIVE INGREDIENT

Inactive Ingredients SD Alcohol 40-B, water, propylene glycol, menthol, tocopheryl acetate,
aloe barbadensis leaf juice, meialeuce alternilolia (tea tree) leaf oil, disodium EDTA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE  
hydrocortisone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-318
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
MENTHOL (UNII: L7T10EIP3A)
TEA TREE OIL (UNII: VIF565UC2G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-318-03	1 in 1 CARTON
1		44 mL in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/16/2010

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture