CalmaDrazos Lidocaine HCl 4% and Menthol 1%

Manufacturer
OPMX LLC
Effective date
2022-06-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:49:48

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4% Menthol 1%

OTC - PURPOSE SECTION

Topical anesthetic Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporary relieves minor pain

Warnings

WARNINGS SECTION

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 this product 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 or apply local heat (such as heating pads) to the area of use or use with a medicated, avoid contact with eyes and mucous membranes, a transient burning sensation may occur upon application but generally disappears in several days. Stop use and ask a doctor if condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24-hour period. BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER. Children under 12 years: ask a doctor

Other Label Information

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water triethanolamine, vitamin E

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 69729-452-72 Calmadrazos

Products

NDC Codes

Ingredients

Complete SPL Sections

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4% Menthol 1%

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water triethanolamine, vitamin E

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24-hour period. BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER. Children under 12 years: ask a doctor

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

temporary relieves minor pain

WARNINGS SECTION

WARNINGS SECTION

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 this product 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 or apply local heat (such as heating pads) to the area of use or use with a medicated, avoid contact with eyes and mucous membranes, a transient burning sensation may occur upon application but generally disappears in several days. Stop use and ask a doctor if condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Topical anesthetic Topical analgesic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 69729-452-72 Calmadrazos

Source Document

Official SPL XML cached by FDA.report ยท DailyMed PDF

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XML bytes
16389

Legacy File Index

FolderFileDate
otce11cc0b1-b375-6f1f-e053-2995a90a1e40.xml2022-06-12
otcd9f8dbb5-def0-dae5-e053-2a95a90a34d4.xml2022-03-12
otcb9cf1661-877c-40f6-e053-2995a90a4c64.xml2021-01-28
otcCalmadrazos.jpg2021-01-28