OFFENSE PLAYER ARTHRITIS PAIN- capsaicin, camphor, menthol, methyl salicylate gel
Delsam Pharma Llc

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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Offense Player™ Arthritis Pain Gel

Drug Facts

Active Ingredients

Capsaicin 0.25%
Camphor 4%
Menthol 10%
Methyl Salicylate 10%

Purpose

Topical Analgesic

USES:

Temporarily relieves the minor aches and pains of muscles and joints associated with:
• Simple back ache • Arthritis • Strains • Bruises • Sprains

WARNINGS:

For external use only.
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 affected area

When using this product
• Avoid contact with eyes or mucous membranes. Do not bandage tightly.
• Stop use and ask a doctor if condition worsens or symptoms persists for more than 7 days.
• Symptoms clear up and occur again within a few days.
• Excessive skin irritation occurs.

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Use only as directed

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

Children under 12 years of age: Ask a doctor.

OTHER INFORMATION:

Store at 20° to 25° C (68° to 77° F).

INACTIVE INGREDIENTS:

Eucalyptus Oil, Carbopol 934, Triethanolamine, Sodium methyl hydroxy benzoate, Sodium propyl hydroxybenzoate, Sodium Edetate, Propylene glycol, Light liquid paraffin, Cetomacrogol -1000, White soft paraffin, Cetostearyl alcohol, Purified Water.

QUESTIONS OR COMMENTS:

1-866-826-1306 between 11am to 4 pm EST, Monday-Friday (or) mail to delsampharma@yahoo.com

EXTRA STRENGTH

With Five ingredients for powerful relief at the site of pain

Distributed by:
DELSAM PHARMA LLC
MAMARONECK NY 10543

Packaging

Delsam-138

OFFENSE PLAYER ARTHRITIS PAIN
capsaicin, camphor, menthol, methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72570-138
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 g in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	4 g in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 g in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
EUCALYPTUS OIL (UNII: 2R04ONI662)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
EDETATE SODIUM (UNII: MP1J8420LU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CETETH-20 (UNII: I835H2IHHX)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72570-138-09	256 g in 1 CONTAINER; Type 0: Not a Combination Product	08/24/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/24/2022

Labeler - Delsam Pharma Llc (081369679)

Revised: 8/2022

Document Id: cd20f763-2563-4d6c-84ec-bfa06803cead

Set id: 2b75a416-922b-4cc7-8b55-a85cda2fb0f4

Version: 1

Effective Time: 20220824

Delsam Pharma Llc