Otc - Active Ingredient
Lidocaine HCl 4%
Numb Gel Anesthetic
FDA Label NDC 76348-595
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Inc. for the product Numb Gel Anesthetic (NDC 76348-595). 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 - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical anesthetic
Indications & Usage
Uses: For temporary relief of pain associated with minor skin procedures
Warnings
For External Use only.
Otc - When Using
When using this product, do not use in or near the eyes • do not use in large quantities, particularly over raw surfaces or blistered areas. • do not use on puncture wounds • for more than one week without consulting a doctor
Otc - Stop Use
Stop Use and ask a doctor if:
- allergic reaction occurs
- condition worsens or does not improve within 7 days
- symptoms clear up and return within a few days
- redness, irritation, swelling, pain or other symptoms begin or increase
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: adults and children 2 years and older: apply to the affected area up to 3 to 4 times a day
children under 2 years - ask a doctor
Inactive Ingredient
Inactive Ingredients: Aloe Barbadensis Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol SD 40B, Glycerin
Other Safety Information
Store at 20 - 25 C (68 - 77 degrees F)
Otc - Questions
Questions? 574-975-3632
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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