Drug Facts
Active Ingredients:
Hydrocortisone Cream 1%
Active Ingredients (In Each Gram)
Maximum Strength Hydrocortisone Plus Moisturizing Aloe
FDA Label NDC 81238-4608
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Western First Aid Safety Dba Aramark for the product Maximum Strength Hydrocortisone Plus Moisturizing Aloe (NDC 81238-4608). 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 drug facts, otc - purpose, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Hydrcortisone 1% ...... Anti Itch
Indications & Usage
Uses: • for the temporary relief of itching associated with minor skin irritations,
inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison
sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis
scrapes • for external genital, feminine, and anal itching • other uses of this product
should be only under the advice and supervision of a doctor
Warnings
Warnings • for external use only • avoid contact with eyes • do not put this product
into rectum by using fingers or any mechanical device or applicator Consult a doctor:
• before use if you have a vaginal discharge (for external feminine itching) • for
external itching, do not exceed the recommended daily dosage or if bleeding occurs •
if condition When using this product: • avoid contact with eyes • do not put this
product into rectum by using fingers or any mechanical device or applicator worsens
or if symptoms persist for more than 7 days or clear up and occur again within a few
days • ask a doctor before use if you are using any other hydrocortisone product
Otc - Do Not Use
Do Not Use • with any other Hydrocortisone product unless you have consulted a
doctor
Otc - 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.
Dosage & Administration
Directions: • For 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: do not use, consult a
doctor • Adults for external anal itching when practical, cleanse the affected area with
mild soap and warm water and rinse thoroughly or by patting or blotting with an
appropriate cleansing pad • Gently dry by patting or blotting with toilet tissue or a
soft cloth before application of this product • Children under 12 years of age: for
external anal itching, consult a doctor
Other Safety Information
Other Information: • Store at controlled
room temperature 15° to 30° C
(59° to 86° F) • Tamper evident. Do not
use if packet is torn, cut, or opened
• Avoid excessive heat and humidity
Inactive Ingredient
Inactive Ingredients: Water, Cetaryl
Alcohol, Glycerin, Ceteareth-20,
Isopropyl Mistrate, EDTA-2NA,
Phenoxyethanol, Tocopheryl Acetate,
Aloe Barbadensis leaf Juice
Product Package
aramark
25 ct. of 1g packets
Part # 608R23
MAXIMUM STRENGTH
HYDROCORTISONE
PLUS MOISTURIZING ALOE
compare to
Hydrocortisone
1% ANTI-ITCH ANALGESIC • FOR THE
TEMPORARY RELIEFOF MINOR SKIN IRRITATIONS
Retain carton for complete product information
MANUFACTURED BY:
Aramark
Lenexa, KS 66219 (913) 269-9611
aramarkuniform.com
25 Count
6 Count
* Please review the disclaimer below.
