Active Ingredient
Hydrocortisone 0.5 %
Hexashield Anti Itch Cream
FDA Label NDC 43136-203
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tai Guk Pharm. Co., Ltd. for the product Hexashield Anti Itch (NDC 43136-203). 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 ingredient, 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.
Label Section Quick Index
Purpose
Anti-Itch
Uses
temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- psoriasis
- poison ivy, oak or sumac
- insect bites
- detergents
- jewelry
- cosmetics
- soaps
- seborrheic dermatitis
- temporarily relieves external anal and genital itching
Other uses of this product should be only under the advice and supervision of doctor
Warnings
For external use only.
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 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 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
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
- 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
for external anal and genital itching, adults :
Other Information
- store at room temperature
- Lot No. & Exp. Date: see box or crimp of tube
Inactive Ingredients
aloe vera leaf, butylated hydroxytolune, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water
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HeXasheild
Relieves skin irritation and rashes due to
- Eczema - Seborrheic Dermatitis - Detergents
- Psoriasis - Poison ivy, Oak & sumac - Jewelry
- Insect bites - Soaps - Cosmetics
HeXasheild
ANTI ITCH CREAM
WITH HEALING ALOE
Fragrance Free plus Soothing Aloe
0.5% Hydrocortisone Cream Regular Strength
Sensitive Skin
Hydrocortisone Cream
REGULAR STRENGTH
Anti-Itch Cream
NET WT 2 oz (57 g)
Dist. LG HOUSEHOLD & HEALTH CARE LTD.
58, SAEMUNAN-RO, JONGNO-GU, SEOUL, KOREA
MADE IN KOREA
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