BUFFERIN PAIN RELIEF- menthol, camphor, and methyl salicylate cream 
Genomma Lab USA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Bufferin® Pain Relief Cream

Drug Facts

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:

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

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

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

Keep out of reach of children.

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

Directions

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

Other information

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

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

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)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton
BUFFERIN PAIN RELIEF 
menthol, camphor, and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-615
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)-100 mg  in 1 g
CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-40 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Water (UNII: 059QF0KO0R)  
glycerin (UNII: PDC6A3C0OX)  
Stearyl alcohol (UNII: 2KR89I4H1Y)  
cetyl alcohol (UNII: 936JST6JCN)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-615-201 in 1 CARTON08/18/2023
156.7 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/18/2023
Labeler - Genomma Lab USA (832323534)

Revised: 8/2023
Document Id: 0825bfb3-ca67-4179-89f1-104d2b8e475a
Set id: abbe91d1-cb83-4329-8199-5ba16cb85e9c
Version: 1
Effective Time: 20230821
 
Genomma Lab USA