OTC Medication Information: Lidocaine 5%

LIDOCAINE 5%- lidocaine cream
TriMarc Labs

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.

Active Ingredient


Lidocaine 5% w/w

Purpose

Topical anesthetic

Use

temporarily relieves pain and itching due to anorectal disorders

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 put directly in rectum by using fingers or mechanical device
  • do not exceed recommended dosage unless directed by a doctor

Stop use and ask doctor if:

  • allergic reaction occurs
  • rectal bleeding 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
Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • When practical, clean area with mild soap and warm water and rinse thouroughly
  • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: Consult a doctor

Other Information

  • Store at 25  deg. C (77F); excursions permitted to 15-30 deg. C (59-86F)

    [see USP Controlled Room Temperature].

Inactive ingredients

water, cetyl alcohol, stearic acid, aloe barbadensis leaf juice, simmondsia chinensis (jojoba) seed oil,

lecithin, hexylene glycol, sodium polyacrylate, caprylyl glycol, ethoxydiglycol, potassium sorbate, phenoxyethanol

Lidocaine 5%

68752015 Label

LIDOCAINE 5%
lidocaine 5% cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68752-015
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
CETYL ALCOHOL
STEARIC ACID
ALOE VERA LEAF
JOJOBA OIL
HEXYLENE GLYCOL
CAPRYLYL GLYCOL
DIETHYLENE GLYCOL MONOETHYL ETHER
POTASSIUM SORBATE
PHENOXYETHANOL
LECITHIN, SOYBEAN
SODIUM POLYACRYLATE (8000 MW)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68752-015-45 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (68752-015-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/01/2011
Labeler — TriMarc Labs (156893695)
Registrant — TriMarc Labs (156893695)
Establishment
Name Address ID/FEI Operations
TriMarc Labs 156893695 manufacture (68752-015)

Revised: 10/2019 TriMarc Labs

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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