Active Ingredients
Hydrocortisone 1%
The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter Llc for the product Harris Teeter Hydrocortisone (NDC 69256-975). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Hydrocortisone 1%
Anti-itch
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
For external use only
in genital area if you have a vaginal discharge
for the treatment of diaper rash
with any other hydrocortisone product unless you have asked a doctor
use only as directed
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
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days
rectal bleeding occurs
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
For itching of skin irritation, inflammation and rashes:
Adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: consult a physician
For external anal and genital itching:
Adults and children 12 years of age and over: 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: do not use, consult a physician
store at 20°–25°C (68°–77°F)
do not use if tube seal under cap is broken
ceteareth-20, cetearyl alcohol, ethylhexylglycerin, glycerin, glyceryl-1-stearate, mineral oil, phenoxyethanol, water, white petrolatum
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