FDA Label for Maximum Strength Hydrocortisone Plus Moisturizing Aloe

View Indications, Usage & Precautions

Maximum Strength Hydrocortisone Plus Moisturizing Aloe Product Label

The following document was submitted to the FDA by the labeler of this product Western First Aid Safety Dba Aramark. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active Ingredients:
Hydrocortisone Cream 1%
Active Ingredients (In Each Gram)


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


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