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NDC 71383-0024-02 MediNumb 40 mg/g Details

MediNumb 40 mg/g

MediNumb is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Valekista Limited. The primary component is LIDOCAINE.

Product Information

NDC	71383-0024
Product ID	71383-024_906c3414-a2c8-4038-9d38-0fd0fbbfdf94
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	MediNumb
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	mg/g
Substance Name	LIDOCAINE
Labeler Name	Valekista Limited
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71383-0024-02 (71383002402)

Pricing Information	N/A
NDC Package Code	71383-024-02
Billing NDC	71383002402
Package	1 TUBE in 1 BOX (71383-024-02) / 56 g in 1 TUBE
Marketing Start Date	2017-04-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0e43648d-3dae-4faf-a6b4-d21c062e32e1 Details

Drug Facts

Active Ingredient

Lidocaine 4%

Purpose

Topical Analgesic

Use

For the temporary relief of pain

Warnings

For external use only

Avoid contact with eyes

Not for prolonged use

Do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clears up and occurs again within a few days
rash or irritation develops, persists or increases

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away: 800-222-1222

Directions

Adults and children 2 years and older

clean the affected area
apply to affected area not more than 3 to 4 times daily
remove residue if desired
Children under 2 years old: Consult a doctor

Other information

Store at 15 to 30°C (59 to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Inactive ingredients

Aloe barbadensis leaf juice, arginine, benzophenone-4, cetyl alcohol, dimethyl sulfoxide, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol; (and) caprylyl glycol (and) potassium sorbate (and) water (and) hexylene glycol, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid

Questions or Comments?

877-557-1135 or www.medinumb.com

SPL UNCLASSIFIED SECTION

Distributed by: Valekista Limited, Pacific Plaza, Western District, HK

PRINCIPAL DISPLAY PANEL - 56 g Tube Box

MEDINUMB™

4% Lidocaine Cream

Pain Relieving Topical Anesthetic

Medicated Cream to Numb The Skin

MAXIMUM STRENGTH

NET WT. 2oz.(56g)

INGREDIENTS AND APPEARANCE

MEDINUMB

lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71383-024
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Arginine (UNII: 94ZLA3W45F)
SULISOBENZONE (UNII: 1W6L629B4K)
Cetyl Alcohol (UNII: 936JST6JCN)
Dimethyl Sulfoxide (UNII: YOW8V9698H)
Tea Tree Oil (UNII: VIF565UC2G)
Phenoxyethanol (UNII: HIE492ZZ3T)
Caprylyl Glycol (UNII: 00YIU5438U)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Hexylene Glycol (UNII: KEH0A3F75J)
Water (UNII: 059QF0KO0R)
Jojoba Oil (UNII: 724GKU717M)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
Stearic Acid (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71383-024-02	1 in 1 BOX	04/30/2017
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part348	04/30/2017

Labeler - Valekista Limited (664452239)

Revised: 7/2017

Document Id: 906c3414-a2c8-4038-9d38-0fd0fbbfdf94

Set id: 0e43648d-3dae-4faf-a6b4-d21c062e32e1

Version: 1

Effective Time: 20170706