NUMB NUTS- lidocaine cream

Numb Nuts by

Drug Labeling and Warnings

Numb Nuts by is a Otc medication manufactured, distributed, or labeled by Miss Smarty Pants Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

For Pain Relieving Cream

Active Ingredient                     Purpose

Lidocaine 4%                           Topical Analgesic

PURPOSE

purpose
topical 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

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.

ASK DOCTOR

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

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.

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

SPL UNCLASSIFIED SECTION

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

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

PRINCIPAL DISPLAY PANEL

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).

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NUMB NUTS 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48095-390
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA FLOWER (UNII: 575DY8C1ER)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
JOJOBA OIL (UNII: 724GKU717M)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
SULISOBENZONE (UNII: 1W6L629B4K)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48095-390-01	1 in 1 BOX
1		14.2 g in 1 TUBE

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	Business Operations
Miss Smarty Pants Enterprises, Inc.		942928669	manufacture