HYDROCORTISONE by CVS Pharmacy / Pharma Pac, LLC HYDROCORTISONE cream

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%.................................... Anti-itch cream

PURPOSE

Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

- eczema - insect bites - poison ivy, poison oak or poison sumac - soaps - detergents - cosmetics
- jewlery - seborrheic dermatitis - psoriasis - other uses of this product: ask 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 immediately.

INDICATIONS & USAGE

Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

- eczema - insect bites - poison ivy, poison oak or poison sumac - soaps - detergents - cosmetics
- jewlery - seborrheic dermatitis - psoriasis - other uses of this product: ask a doctor

Other information

- store at room temperature. Protect from freezing and excessive heat.
- see carton or tube crimp for lot number and expiration date.

WARNINGS

Warnings

For external use only.

Do not use:
- in the eyes - for the treatment of diaper rash

Ask a doctor before use if you are using any other hydrocortisone product

Stop use and ask a doctor if

- condition worsens, or if symptoms persist for more than 7 days

- symptoms last more than 7 days or clear up and occur again within a few days

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

DOSAGE & ADMINISTRATION

Directions 


- adults and children 2 years and older:apply to affected area not more than 3 to 4 times daily
- children under 2 years:do not use, ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients

aloe barbadensis leaf juice, avena sativa kernal flour oat, beeswax, cetyl alcohol, citric acid,
glyceryl stearate, isopropyl myristate, methylparaben, PEG-40 stearate, polysorbate 60,
propylene glycol, propylparaben, purified water, sodium citrate, sodium stearate, sorbic acid,
stearyl alcohol, tocopheryl acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-322
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
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
SORBIC ACID (UNII: X045WJ989B)
SODIUM STEARATE (UNII: QU7E2XA9TG)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WHITE WAX (UNII: 7G1J5DA97F)
OATMEAL (UNII: 8PI54V663Y)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-322-20	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/19/2009

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

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