Active Ingredient
Hydrocortisone 1%
Anti-itch With Aloe
FDA Label NDC 63868-688
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Anti-itch With Aloe (NDC 63868-688). 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, indications & usage, warnings, stop use and ask a doctor, keep out of the reach of children, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Itch
Indications & Usage
For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to
- insect bites
- eczema
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external feminine genital 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 the treatment of diaper rash, consult a doctor.
For external genital itching if you have a vaginal discharge, consult a doctor.
Stop Use And Ask A Doctor
- Conditions worsen
- Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
Other Information
- Store at controlled room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
Aloe Vera (Aloe Barbadensis) leaf juice, Cetostearyl alcohol, Edatate Disodium, Glyceryl monostearate, Methylparaben, Mineral Oil, White Petrolatum, Propylene glycol, Purified Water, Sorbitan Monostearate, Polysorbate 60
When Using This Product
- Avoid contact with the eyes
- do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
- for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In the case of bleeding, stop use, consult a doctor.
- do not put this product into the rectum by using fingers or any mechanical device or applicator.
Directions
Adults and children 2 years and older
- apply to affected area not more than 3 to 4 times daily.
- do not use, consult doctor
- adults when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
- Children under 12 years of age with external anal ithcing consult a doctor.
Children under 2 years of age
For external and anal itching
Distributed By
Distributed By CDMA Inc.
43157 W 9 Mile Rd.
Novi, MI. 48375
www.qualitychoice.com
Questions: 800-935-2362
Product PRC
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