Hot And Cold With Lidocaine-ra
FDA Label NDC 72351-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sotac Pharmaceuticals Private Limited for the product Hot And Cold With Lidocaine-ra (NDC 72351-003). 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 drug facts, active ingredients, purposes, warnings, do not use, when using section, if pregnant or breast-feeding,, keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

HOT AND COLD CREAM with LIDOCAINE-RA
PAIN RELIEVING CREAM
Drug Facts

Active Ingredients

Lidocaine HCl 4%
Menthol 1%

Purposes

Lidocaine- Topical anesthetic,
Menthol- Topical Analgesic

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 consulting a doctor

When Using Section

  • Use only as directed. Read and follow all directions and warnings on this label
  • rare cases of serious burns have been reported with products of this type
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
  • avoid contact with eyes and mucous membranes
  • a transient burning sensation may occur upon application but generally disappears in several days

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children Section

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

Dosage & Administration

adults and children over 12 years:

  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

    • children 12 years or younger: ask a doctor

Inactive Ingredient Section

Butylated hydroxyl toluene,cetostearyl alcohol,cetomacrogol 1000,cetyl alcohol,disodium EDTA,disodium hydrogen phosphate,light liquid paraffin,propylene glycol,sorbic acid,transquitol P, white petroleum jelly
Keep Carton As It Contains Important Information
Close cap tightly between uses.

Outer Label

Temporarily relieves minor pain

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