Lidocaine by Marlex Pharmaceuticals Inc LIDOCAINE cream

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by Marlex Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

LIDOCAINE 4%- lidocaine cream

Marlex Pharmaceuticals, 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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Lidocaine 4% Topical

Drug Facts

Active ingredient

Lidocaine 4%

Purpose

Pain & Itch Relief

Use

for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

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 clear 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

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor

Other information

• May be applied under occlusive dressing
  
• store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) 

Inactive ingredients

Benzyl alcohol, carbopol 940, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, trolamine and vitamin E acetate

PRINCIPAL DISPLAY PANEL - 15g Tube Carton

Lidocaine 4% Topical Anesthetic Cream

Pain & Itch Relief Cream NET WT. 0.5 oz.(15g)

PRINCIPAL DISPLAY PANEL - 30g Tube Carton

Lidocaine 4% Topical Anesthetic Cream

Pain & Itch Relief Cream NET WT. (30g)

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-672
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-672-96	1 in 1 CARTON	12/01/2018
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10135-672-99	1 in 1 CARTON	12/01/2018
2		30 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 NOT FINAL	part348	12/01/2018

Labeler - Marlex Pharmaceuticals Inc (782540215)