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LidoCream 4 by Golden Touch LLC

Dosage form: cream
Ingredients: LIDOCAINE 4g in 100g
Labeler: Golden Touch LLC
NDC Code: 52763-401

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.

LidoCream 4

Active ingredient

Lidocaine 4% W/W

Purpose

Topical Anesthetic

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

Uses

For the temporary relief of pain and itching due to

  • minor burns
  • minor skin irritations

Warnings

For external use only

When using this product

  • Avoid contact with the eyes 
  • Do not use in large quantities particularly over raw surfaces or blistered areas.
  • Do not exceed recommended dosage unless directed by a doctor


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
  • notice any unusual effects such as blurred vision, dizziness or drowsiness, difficulty in breathing, trembling, chest pain or irregular heart beat

Directions
  • Adults and children 2 years and older: apply externally to the affected area not more than 3 to 4 times daily   
  • Children under 2 years of age: consult a doctor 

Inactive ingredients

Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Monooleate, SD Alcohol 40-B, Simmondsia Chinensis (Jojoba) Seed Oil, Water

Packaging

LIDOCREAM 4 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52763-401
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
BENZYL ALCOHOL 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
EDETATE DISODIUM 
GLYCERIN 
GLYCERYL OLEATE 
ALCOHOL 
SIMMONDSIA CHINENSIS SEED 
WATER 
Packaging
#Item CodePackage Description
1NDC:52763-401-601 TUBE in 1 CARTON
160 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/01/2010
Labeler - Golden Touch LLC (194284147)
Establishment
NameAddressID/FEIOperations
Golden Touch LLC194284147manufacture(52763-401)

 
Golden Touch LLC

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Medically reviewed on Nov 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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