Drug Facts
Active Ingredients Hydrocortisone, USP 1%
Hydrocortisone With Aloe Cream
FDA Label NDC 13709-317
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Hydrocortisone With Aloe (NDC 13709-317). 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, purpose, uses:, warnings:, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-itch
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
■ jewelry ■ detergents ■ cosmetics ■ psoriasis ■ seborrheic dermatitis ■ for external genital, feminine and anal itching ■ other uses of this product should be only under the advice and
supervision of a doctor
Warnings:
For external use only Do not use ■ for external feminine itching 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 the eyes ■ do not begin the use of any other hydrocortisone product unless directed by a doctor ■ for external anal itching: ■ do not use more than directed unless directed by a doctor ■ do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Use And Ask A Doctor If
■ symptoms last for more than 7 days. ■ the condition gets worse ■ symptoms clear up and occur again in a few days ■ rectal bleeding occurs, consult doctor promptly.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222
Directions
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 If pregnant or breast-feeding ■ ask a health professional before use.
For external anal itching Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product Children under 12 years of age: consult a doctor
Other Information:
■ Storage temperature: not to exceed 30°C (86°F). Protect from freezing.
■ Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients:
Aloe vera concentrate, benzyl alcohol, ceteareth 20, cetearyl alchol, cetyl palmitate, glyceryl, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water. May contain citric acid or sodium citrate solution to adjust pH.
Safe Handling Warning
TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING
Package Label.Principal Display Panel
Hydrocream 1% (Pk Ic104 Rev1 Hydrocream Box 2oz)
1oz (Pk Ic103 Rev1 Hydrocream Tube Page 0001)
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