BURN RELIEF CREAM MAX STRENGTH (81310-004-27)

Manufacturer
STRETTON ONLINE LTD.
Effective date
2021-11-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:26:25

Label at a glance#

ProductBURN RELIEF MAX STRENGTH
Active ingredientLIDOCAINE, MENTHOL
Label structure13 sections

Indications and uses

For the temporary relief of pain and/or itching associated with minor burns, sunburn, minor cuts, scrapes andinsect bites or minor skin irritations

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient


Lidocaine HCI 4%
Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and/or itching associated with minor burns, sunburn, minor cuts, scrapes andinsect bites or minor skin irritations

Warnings

WARNINGS SECTION

for external use only.

Do Not Use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • use only as directed. Read and follow all directions and
  • warnings on this carton.
  • Warnings
  • When using this product
  • Do not use
  • For external use only.
  • 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
  • rare cases of serious burns have been reported with products of this type
  • if the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,
  • discontinue use of this product and consult a doctor.
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
  • a transient burning sensation may occur upon application but generally disappears in several days
  • avoid contact with eyes
  • avoid contact with mucous membranes
  • do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop Use and Ask a Doctor If

OTC - STOP USE SECTION

  • 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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature
  • avoid direct sunlight
  • Do not use if carton is open or if tamper evident foil is breached or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe barbadensis Leaf Juice, Aminomethyl Propanol, Isohexadecane, Hydroxyethyl Acrylate /Sodium Acryloyldimethyl Taurate Copolymer, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Cetearyl Alcohol (and) Dicetyl Phosphate (and) Ceteth-10 Phosphate, Glyceryl Stearate, Dimethicone, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin, SD Alcohol, Steareth-21, Water

Questions

OTC - QUESTIONS SECTION

Child-resistant packaging.
Close cap tightly between uses.

Stretton Online Ltd
2160 Union Place
Simi Valley
CA 93065
United States
Medcosa.com
info@medcosa.com
+ 1 (562) 337-0165

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burn Relief Cream NDC: 81310-004-27

BOTTLEBOTTLE

BOXBOX

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81310-00481310-004-27

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d0ba694-a43f-d3f9-e063-6294a90af397c19d65ba-e111-abc1-e053-2995a90a24eb2023-12-21WarningsExact identifier
spl set id: c19d65ba-e111-abc1-e053-2995a90a24eb