Delsam Pharma's Offense Player Ultra

Offense Player Ultra by

Drug Labeling and Warnings

Offense Player Ultra by is a Otc medication manufactured, distributed, or labeled by Delsam Pharma Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OFFENSE PLAYER ULTRA- camphor, menthol, methyl salicylate cream 
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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Delsam Pharma's Offense Player Ultra

Drug Facts

Active ingredient

Camphor 4%

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

USE

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

Simple backache  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°C to 25°C (68° to 77°F)

INACTIVE INGREDIENTS

Benzyl Alcohol, Butylated Hydroxytoluene, Carbomer 934, Citric Acid, Cresmer RH 40, Disodium EDTA, Propylene Glycol, Purified Water & Triethanolamine

Questions or Comments

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

ULTRA STRENGTH

TOPICAL ANALGESIC CREAM

With three ingredients for powerful relief at the side of pain

Distributed by:

DELSAM PHARMA LLC

MAMARONECK NY 10543

Packaging

OFFENSE PLAYER ULTRA 
camphor, menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	40 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	300 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72570-130-12	341 g in 1 CONTAINER; Type 0: Not a Combination Product	07/01/2021	09/27/2021
2	NDC: 72570-130-09	1 in 1 CARTON	09/06/2021	09/27/2021
2		256 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	07/01/2021	09/27/2021

Labeler - Delsam Pharma Llc (081369679)

Revised: 9/2021

Document Id: 374ba471-9df7-4b66-a8a3-13b4e6e3ce67

34390-5

Set id: 2d40fb54-1ff8-458f-93e7-fe37c914257b

Version: 3

Effective Time: 20210927