Topcare Pain Relieving Cream
FDA Label NDC 36800-470

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Pain Relieving (NDC 36800-470). 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, uses, warnings, when using this product, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

Active Ingredient

Lidocaine HCl 4%

Purpose

Topical analgesic

Uses

for the temporary relief of pain.

Warnings

For external use only

When Using This Product

  • ♦avoid contact with eyes
  • ♦do not apply to wounds or damaged skin
  • ♦do not bandage tightly
  • ♦do not use with heating pads or other heating devices
  • ♦as with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product
  • ♦do not use in large quantities, particularly over raw surfaces or blistered areas

Otc - Stop Use

Discontinue use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • ♦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: do not use, consult a doctor

Other Information

store at room temperature

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol denat., Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearare SE, Phenoxyethanol, Steareth-21, Water.

Questions Or Comments?

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Principal Display Panel - 77 G Bottle Carton

TopCare
health®

COMPARE TO ASPERCREME® ODOR FREE WITH 4% LIDOCAINE ACTIVE INGREDIENT*

ODOR FREE
Pain Relieving Cream
with Lidocaine HCl 4%
MAXIMUM STRENGTH
•Temporary Relief of Pain
•Non-Greasy •Fast Acting •With Aloe

NET WT 2.7 OZ (77 g)

• OUR PHARMACISTS •
RECOMMEND

Principal Display Panel (77 g Bottle Carton)

Principal Display Panel (77 g Bottle Carton)

* Please review the disclaimer below.