MEDINUMB- lidocaine cream

MediNumb by

Drug Labeling and Warnings

MediNumb by is a Otc medication manufactured, distributed, or labeled by Valekista Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part348	04/30/2017

Labeler - Valekista Limited (664452239)