HARRIS TEETER MAXIMUM STRENGTH ANTI-ITCH- hydrocortisone ointment

Harris Teeter Maximum Strength Anti-Itch by

Drug Labeling and Warnings

Harris Teeter Maximum Strength Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Harris Teeter. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                          Purpose

Hydrocortisone 1%.........................................Anti-itch

PURPOSE

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema, psoriasis, poison ivy oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis
• temporarily relieves external anal and genital itching
• other uses of this product should only be under the advice and supervision of a doctor

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• in the genital area if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Consult a doctor.

WHEN USING

When using this product

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

STOP USE

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

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

INDICATIONS & USAGE

Directions

• for itching of skin irritation,
• 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: ask a doctor
• for external anal and genital itching, 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 soft cloth before applying
• apply to affected area not more 3 to 4 times daily
• chldren under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 20°-25°C (68°-77°F)
• lot no. & exp. date: see box or crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

cetyl alcohol, methylparaben, petrolatum, propylparaben, sorbitan monostearate, stearly alcohol

DOSAGE & ADMINISTRATION

Distributed by:

Harris Teeter, LLC

Matthews, NC 28105

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HARRIS TEETER MAXIMUM STRENGTH ANTI-ITCH 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72036-406
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
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72036-406-28	1 in 1 CARTON	04/17/2017
1		28 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 not final	part348	04/17/2017

Labeler - Harris Teeter (047279351)