Bufferin ® Pain Relief Cream

Manufacturer
Genomma Lab USA
Effective date
2023-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:26:59

Label at a glance#

ProductBufferin Pain Relief
Active ingredientMENTHOL, (+)-, CAMPHOR, (-)-, METHYL SALICYLATE
Label structure11 sections

Indications and uses

Temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

use only as directed Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daiIy Chidren under 12 years of age: ask a doctor

Storage and handling

store at 15 to 30"C (59 to 86"F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%, Menthol 10% Methyl salicylate 30%

Purpose

OTC - PURPOSE SECTION

Topical analgesics

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Allergy alert

SPL UNCLASSIFIED SECTION

  • If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area.

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with eyes or mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor If

OTC - STOP USE SECTION

  • redness is present or irritation or rash develops
  • conditions worsen or symptoms clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only as directed

SPL UNCLASSIFIED SECTION

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daiIy

SPL UNCLASSIFIED SECTION

Chidren under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 15 to 30"C (59 to 86"F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, Glycerol monostearate (GMS), Stearyl alcohol, Cetyl alcohol, Hemp seed oil, Stearic acid, Isopropyl palmitate, Polyacrylic acid, Potassium cetyl phosphate, Triethanolamine (TEA), Methylparaben, Propylparaben

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-994-3666

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
GENOMMA LAB USA, INC.,
HOUSTON, TX 77098

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

irwin
naturals®

BUFFERIN®
+ 1000 mg
Hemp Seed Oil*
PER TUBE
CURATED FROM IRWIN NATURALS®

PAIN RELIEF CREAM
ULTRA STRENGTH

FAST ACTING
DEEP PENETRATING
*FOR SKIN CONDITIONING

FAST RELIEF OF MUSCLE,
BACK AND JOINT PAIN

NET. WT 2.0 OZ (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton
PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-61550066-615-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
d4678ab4-e3c3-4630-859b-f5b687c0fc7fabbe91d1-cb83-4329-8199-5ba16cb85e9c2025-01-29WarningsExact identifier
spl set id: abbe91d1-cb83-4329-8199-5ba16cb85e9c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.