Otc - Active Ingredient
Lidocaine 5% W/W
Retalief Lidocaine 5 Cream
FDA Label NDC 69618-075
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Retalief Lidocaine 5 (NDC 69618-075). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Local Anesthetic Anorectal (Hemorrhoidal) Cream
Indications & Usage
helps relieve the pain, itching, and burning, associated with hemorrhoids and anorectal disorders
Warnings
FOR EXTERNAL USE ONLY
Otc - When Using
When using this product
- avoid contact with eyes
- do not use more than directed unless directed by a doctor
- do not put directly into the rectum by using fingers or any mechanical device or applicator
Otc - Stop Use
Stop use and ask a doctor if
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- an allergic reaction occurs
- symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
- symptoms clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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
Directions
- when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
- Gently dry by patting or blotting with toilet tissue or a soft cloth before applying
- Adults and children 12 years of age and older: apply externally to the affected area not more than 6 times a day.
- children under 12 years of age: consult a doctor.
Other Safety Information
Store between 20°-25° C (68°-77° F)
Inactive Ingredient
Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cholesterol, Isopropyl myristate, Mineral Oil, Polysorbate 80, Propylene Glycol, Purified Water, Tocopherol, Trolamine.
Package Label.Principal Display Panel
NDC 69618-075-78
Reliable 1 Laboratories
Rectalief
Anorectal Cream
Lidocaine 5%
Relieves Pain, Itching & Burning
Highest Strength of Non-Rx Lidocaine Available
1OZ (30gm)
QUESTIONS
1-516-341-0666 Monday- Friday
Distributed by
Reliable 1 Labs
99 W. Hawthorne Ave #610
Valley Stream, NY 11580
www.reliable1labs.com
Made in China
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