FDA Label for Hydrocortisone
View Indications, Usage & Precautions
Hydrocortisone Product Label
The following document was submitted to the FDA by the labeler of this product Mckesson. 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.
Other
Drug Facts
Otc - Active Ingredient
Hydrocortisone Cream 1%
Active Ingredients (in each gram)
Hydrocortisone USP 10 mg
Otc - Purpose
Purpose
Antipruritic (Anti Itch)
Indications & Usage
Indications:
For the temporary relief of itching associated with minor skin irritation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis scrapes
For the temporary relief of 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 exceed the recommended daily dosage unless directed by a doctor
- Do no use for treatment of diaper rash
- In case of bleeding, consult a doctor promptly
- 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 worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days discontinue use of this product
- Do not put this product into rectum by using fingers or any mechanical device or applicator
Consult a doctor:
When using this product:
Otc - Stop 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 1-800-222-1222
Dosage & Administration
Directions:
- For adults and children 2 years of age and older: apply externally 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 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 or age; for external anal itching, consult a doctor.
Other Safety Information
Other Information:
- Store at controlled room temperature 59* to 86*F (15* to 30*C)
- Avoid excessive heat and humidity
- Tamper Evident. Do not use if packet is torn, cut or opened
Inactive Ingredient
Inactive Ingredients:
Benzoic acid, chlorphenesin, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80, purified water, titanium dioxide, trisodium citrate.
Otc - Questions
Questions? Call 1-800-777-4908
Package Label.Principal Display Panel
NDC 68599-1182-2
Hydrocortisone Cream
Effective itch and rash relief cream.
NET WEIGHT
0.9 g (0.03 oz)
MFR # 118-82464
NDC 68599-1182-2
McKesson
Hydrocortisone Cream
NET WEIGHT
0.9 g (0.03 oz)
144 PACKS PER BOX
MFR # 118-82464
NDC 68599-1182-2
McKesson
Hydrocortisone Cream
NET WEIGHT
0.9 g (0.03 oz)
144 PACKS PER BOX
12 BOXES PER CASE
MFR # 118-82464
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