Otc - Active Ingredient
DRUG FACTS
For Pain Relieving Cream
Active Ingredient Purpose
Lidocaine 4% Topical Analgesic
Numb Nuts
FDA Label NDC 48095-390
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Miss Smarty Pants Enterprises, Inc. for the product Numb Nuts (NDC 48095-390). 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 - do not use, otc - ask doctor, otc - stop use, 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
Purposetopical analgesic
Indications & Usage
Uses
for the temporary relief of pain associated with minor skin irritations due to groin area hair removal.
Warnings
WARNINGS
For external use only.
Avoid contact with the eyes
Otc - Do Not Use
Do not use
with other creams or medications
in large quantities, particularly over raw surfaces or blistered areas
if you have had a severe allergic reaction (e.g. severe rash, hives, difficulty breathing, dizziness) to any anesthetic medicine
if there are signs of infection or tissue damage in the affected area.
Otc - Ask Doctor
Ask a doctor before use if you have heart or neurological conditions.
Otc - Stop Use
Stop use and ask a doctor if
you develop a persistent rash
side effects occur
condition worsens or symptoms persist for more than 7 days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact poison control center right away.
Dosage & Administration
Directions
For adult use only. Apply a small amount of cream to the groin area between 15 and 30 minutes prior to groin area hair removal. Do not rub in. A thin layer of cream should be visible on the skin.
Information For Patients
Other information
Cream is packaged with an imprinted wrap around neck of tube
do not use if carton is damaged or open, or if imprinted wrap around neck of tube is damaged or missing.
See crimp of tube for lot number and expiration date
Store at room temperature (68 to 77 degrees F, 20 to 25 degrees C)
Inactive Ingredient
Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Cetyl Alcohol, Hexylene Glycol, Phenoxyethanol, Potassium Sorbate, Simmondsia Chinesis (Jojoba) Seed Oil, Sodium Polyacrylate, Stearic Acid, Water
Other
Numb Nuts
The Manscaper's Pain Relieving Cream
Pakage contents:
1 Tube [0.5 oz (14.2 g)] of pain relieving cream
for more information visit
www.numbnuts.com
Package Label.Principal Display Panel
NUMB NUTS
The Manscapers Pain Relieving Cream
Doctor Formulated
Pain Relieving Cream with Aloe
NUMB NUTS Pin Relieving Cream with Aloe
The Manscaper's Pain Relieving Cream
Net Wt 0.5 oz (14.2 g)
Created and manufactured for
Miss Smarty Pants Enterprises, Inc.
PO Box 10446, Beverly Hills, CA 90213
Packaging and Pain Relieving Cream-Made in the USA
Numb Nuts Pain Relieving Cream with aloe
The manscapers pain relieving cream
Net Wt 0.5 oz (14.2g)
4% Lidocaine
Do Not Use if imprinted wrap around neck of tube is damaged or missing.
Created and manufactured for Miss Smarty Pants Enterprises, Inc.
PO Box 10446 Beverly Hills, CA 90213
Pain Relieving Cream-Made in USA
This unit is packaged in an outer container. Please see outer container for drug facts information.
See crimp of tube for lot number and expiration date.
Store at room temperature (8 to 77 degrees F, 20 to 25 degrees C).
Numbnutsouterbox (Nnboxpdp)
Numbnutsdrugpanel (Nndrugpanel)
Nntubelabel (Nntube)
* Please review the disclaimer below.
