BUFFERIN PAIN RELIEF- menthol, camphor, and methyl salicylate cream

Bufferin Pain Relief by

Drug Labeling and Warnings

Bufferin Pain Relief by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• 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

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

• 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

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

BUFFERIN PAIN RELIEF 
menthol, camphor, and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-615
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 SALICYLATE	300 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-615-20	1 in 1 CARTON	08/18/2023
1		56.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/18/2023

Labeler - Genomma Lab USA (832323534)