Dragon Lidocaine Pain Cream
FDA Label NDC 50066-623

15 label sections · Submitted to the FDA by Genomma Lab Usa · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Dragon Lidocaine Pain (NDC 50066-623). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed by:
Genomma Lab USA, Inc.,
Houston, TX 77027

Active Ingredient

Lidocaine HCl 4%

Purpose

Topical analgesic

Use

For the temporary relief of pain

Warnings

For external use only

Otc - Do Not Use

Do not use

  • in large quantities, particularly over raw surfaces or blister areas
  • on wounds or damaged skin.

Otc - When Using

When using this product

  • use only as directed
  • avoid contact with eyes
  • do not apply tight bandages
  • do not apply a heating pad to treated skin

Otc - Stop Use

Stop use and ask a doctor if

  • conditions worsen or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental ingestion.

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

Directions

  • use only as directed
  • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

    Children under 12 years of age: ask a doctor

Other Information

  • Store at room temperature.
  • Close cap tightly after use

Inactive Ingredients

aloe barbadensis leaf extract, ethylhexylglycerin, ethylhexyl stearate, isopropyl myristate, phenoxyethanol, polysorbate 20, propylene glycol, sodium acrylates copolymer, trideceth-6, water.

Questions Or Comments?

Call toll free 1 877 994 3666.

Principal Display Panel - 76.5 G Tube Carton

POMADA
DRAGON®

LIDOCAINE HCl 4%
MAX STRENGTH

PAIN NUMBING CREAM

REDUCE PAIN RECEPTOR SENSITIVITY

Works Fast

Hours of relief

Odor free

NET. WT 2.7 oz (76.5 g)

Principal Display Panel (76.5 g Tube Carton)

Principal Display Panel (76.5 g Tube Carton)

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