LIDOCAINE- lidocaine cream 
Marlex Pharmaceuticals Inc

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Lidocaine 4 Percent Topical Cream

LIDOCAINE 4%- lidocaine cream

MarlexPharmaceuticals, 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.

Donotusein 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

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL- 15gTubeCarton

Lidocaine 4% Topical Anesthetic Cream

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

672-96

PRINCIPAL DISPLAY PANEL-30gTube Carton

Lidocaine 4% Topical Anesthetic Cream

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

672-99

LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-672
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10135-672-961 in 1 CARTON12/01/2018
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10135-672-991 in 1 CARTON12/01/2018
230 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/01/2018
Labeler - Marlex Pharmaceuticals Inc (782540215)

Revised: 11/2023
Document Id: 09ab51f5-ecf0-fe6f-e063-6394a90adbc6
Set id: 4de2bc60-dc4a-4417-984f-eabab0e926a6
Version: 5
Effective Time: 20231108
 
Marlex Pharmaceuticals Inc