FDA Label for Bufferin Pain Relief

View Indications, Usage & Precautions

Bufferin Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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

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


Active Ingredients



Camphor 4%, Menthol 10% Methyl salicylate 30%


Purpose



Topical analgesics


Uses



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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings



For external use only


Allergy Alert



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

Do Not Use



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

Otc - Ask Doctor



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


When Using This Product



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

Stop Use And Ask A Doctor If



  • 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



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

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


Directions



  • use only as directed

Other Information



  • 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



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?



Call toll free 1-877-994-3666


Principal Display Panel - 56.7 G Tube Carton



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)


* Please review the disclaimer below.