LIDOCAINE 4% CREAM- lidocaine cream 
Galt Pharmaceuticals, LLC

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% CREAM - lidocaine cream

Galt Pharmaceuticals, LLC

ACTIVE INGREDIENT(S)

Lidocaine 4%w/w

PURPOSE

Topical anesthetic

KEEP OUT OF REACH OF CHILDREN

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

USE(S)

Uses temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites

WARNINGS

For external use only.

WHEN USING THIS PRODUCT

When using this  product

  • do not use in or near the  eyes.
  • do  not use in large quantities, particularly over raw surfaces or blistered areas.

STOP USE AND ASK DOCTOR IF

Stop use and ask a doctor if

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms  begin or increase

DIRECTIONS

  • Adults and Children 2 years and older: Apply externally to the affected area up to 3 - 4 times daily.
  • Children under 2 years of age: Consult a doctor.

STORAGE

Store at USP controlled room temperature  20°-25°C (68°-77°F).

INACTIVE INGREDIENTS


Benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.

PRINCIPAL DISPLAY PANEL

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LIDOCAINE 4% CREAM 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61825-701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 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)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61825-701-0510 in 1 CARTON12/01/201412/22/2020
15 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/201412/22/2020
Labeler - Galt Pharmaceuticals, LLC (079214973)

Revised: 2/2021
 
Galt Pharmaceuticals, LLC