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Name:Numb Nuts
Manufacturer:Miss Smarty Pants Enterprises, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Numb Nuts The Manscaper's Pain Relieving Cream

NUMB NUTS  - lidocaine cream 
Miss Smarty Pants Enterprises, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Numb Nuts The Manscaper's Pain Relieving Cream

DRUG FACTS

For Pain Relieving Cream

Active Ingredient                     Purpose

Lidocaine 4%                           Topical Analgesic

purpose
topical analgesic

Uses

for the temporary relief of pain associated with minor skin irritations due to groin area hair removal.

WARNINGS

For external  use only.

Avoid contact with the eyes

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.

Ask a doctor before use if you have heart or neurological conditions.

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.

Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

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.

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)


Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Cetyl Alcohol, Hexylene Glycol, Phenoxyethanol, Potassium Sorbate, Simmondsia Chinesis (Jojoba) Seed Oil, Sodium Polyacrylate, Stearic Acid, Water

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

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

numbnutsdrugpanel

nntubelabel


NUMB NUTS 
lidocaine cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:48095-390
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 4 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA FLOWER  
CAPRYLYL GLYCOL  
CETYL ALCOHOL  
HEXYLENE GLYCOL  
PHENOXYETHANOL  
POTASSIUM SORBATE  
JOJOBA OIL  
STEARIC ACID  
WATER  
SULISOBENZONE  
DIMETHYL SULFOXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:48095-390-01 1 TUBE ( TUBE) in 1 BOX contains a TUBE
1 14.2 g in 1 TUBE This package is contained within the BOX (48095-390-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 06/10/2010

Labeler - Miss Smarty Pants Enterprises, Inc. (942928669)
Registrant - Miss Smarty Pants Enterprises, Inc. (942928669)
Establishment
Name Address ID/FEI Operations
Miss Smarty Pants Enterprises, Inc. 942928669 manufacture

Revised: 08/2010 Miss Smarty Pants Enterprises, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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