Signature Care Lidocaine Cream
FDA Label NDC 21130-544

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands Llc for the product Signature Care Lidocaine Cream (NDC 21130-544). 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, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical anesthetic

Uses

  • Temporarily relieves minor pain

Warnings

For external use only

Do Not Use

  • on large areas of the body or on cut,irritated or swollen skin
  • on puncture wounds
  • for more than one week without consultanting a doctor

When Using This Product

use only as directed. read and follow all directions and warnings on this carton.

do not allow contact with the eyes

do not bandage or apply local heat (such as heating pads) to the area of use.

Stop Use And Ask A Doctor If

  • condition worsens
  • symptons persist for more than 7 days or clear up and occur again within a few days.
  • If pregnant or breast feeding, ask a health professional before use.

Keep This And All Drugs Out Of The Reach Of Children And Pets.

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

Directions

  • Adults and children over 12 years: 
  • apply a thin layer ot affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • Children under 12 years  or younger: ask a doctor

Other Information

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

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 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 Stearate, Phenoxyethanol, SD Alcohol 40, Steareth-21, Water (purified)

Questions? 1-888-723-3929

Principal Panel-Bottle

Signature Care  NDC 21130-544-27

Maxium Strength

4% Lidocaine

Pain Relieving Cream

NET WT. 2.7 oz (76g)

Principal Panel - Carton

Signature Care NDC 21130-544-27

Maxium Strength

4% Lidocaine

Pain Relieving Cream

NET WT. 2.7 oz (76 g)

* Please review the disclaimer below.