HARRIS TEETER ANTI-ITCH COOLING RELIEF- hydrocortisone gel

Harris Teeter Anti-Itch Cooling Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                             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, inflammation, and rashes:
• 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 than 3 to 4 times daily
• children 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
carbomer 940, decolorized aloe vera leaf, glycerin, methylparaben, oat kernal oil, propylene glycol, propylparaben, sodium hydroxide, sorbitan monostearate, stearyl alcohol, water, white wax

DOSAGE & ADMINISTRATION

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC

MATTHEWS, NC 28105

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HARRIS TEETER ANTI-ITCH COOLING RELIEF 
hydrocortisone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72036-408
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
CARBOMER 940 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
OAT KERNEL OIL (UNII: 3UVP41R77R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72036-408-28	1 in 1 CARTON	04/19/2017
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	04/19/2017

Labeler - Harris Teeter (047279351)