HYDROCORTISONE 1 ANTI ITCH- hydrocortisone acetate ointment 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

CVS Pharmacy, Inc. Hydrocortisone 1% Drug Facts

Active ingredient

Hydrocortisone acetate 1.12% (equivalent to hydrocortisone 1%)

Purpose

Anti-itch

Uses

•
temporarily relieves external anal itching
•
other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only.

Do not use

•
for the treatment of diaper rash. Ask a doctor.

When using this product

•
avoid contact with the eyes
•
do not use more than directed unless told to do so by a doctor
•
do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

•
condition worsens
•
symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
•
rectal bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

•
adults:
•
when practical, clean the affected area with mild soap and warm water and rinse thoroughly
•
gently dry by patting or blotting with toilet tissue or a soft cloth before applying
•
apply to affected area not more than 3 to 4 times daily
•
children under 12 years of age: ask a doctor

Other information

•
store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe barbadensis leaf juice, white petrolatum

Questions or comments? 1-800-719-9260

Package/Label Principal Display Panel

MAXIMUM STRENGTH

Relieves ITCH Fast

Effective Relief of External Anal Itching

Compare to the active ingredient in Preparation H® Hydrocortisone Cream

Anti-Itch Ointment

HYDROCORTISONE 1%

RELIEVES EXTERNAL ITCH

Maximum Strength without a prescription

Effective relief of external anal itch

Hydrocortisone 1% Carton Image 1

Hydrocortisone 1% Carton Image 1

Hydrocortisone 1% Carton Image 2

Hydrocortisone 1% Carton Image 1

Hydrocortisone 1% Carton Image 2

HYDROCORTISONE 1  ANTI ITCH
hydrocortisone acetate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-998
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1.12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-998-641 in 1 CARTON06/09/200507/21/2015
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/09/200507/21/2015
Labeler - CVS Pharmacy (062312574)

Revised: 11/2017
Document Id: 87dfad6c-2cec-40c3-a775-5bab6764eb60
Set id: 6688e262-6ac8-4641-93d4-7086386079d2
Version: 2
Effective Time: 20171122
 
CVS Pharmacy