TRANSDERM-IQ- capsaicin, lidocaine, menthol, methyl salicylate ointment

Transderm-iQ by

Drug Labeling and Warnings

Transderm-iQ by is a Otc medication manufactured, distributed, or labeled by Pocono Coated Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Capsaicin 0.0375%

Lidocaine 4%

Menthol 10%

Methyl Salicylate 20%

Purpose

Topical analgesic

Uses

Temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis muscle strains sprains  bruises

Warnings

For external use only

• use only as directed. Read and follow all directions and warnings on this carton. 
• avoid contact with eyes and mucous membranes
• do not use at the same time as other topical analgesics
• do not use on open wounds, cuts, damaged or infected skin
• do not use with bandage or heating pad.

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding or if you have sensitive skin, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

• If swallowed, get medical help or contact Poison Control Center right away

Directions

Adults 18 years and children 12 years and older:

• apply product directly to affected area
• product may be used as necessary, but should not be used more than four times per day
• wash hands immediately afterwards.

Questions/Comments:

(704)729-4638

Inactive ingredients:

Purified Water, Mineral Oil, Isopropyl Myristate, Cetyl Alcohol, Glycerol Monostearate, Stearic Acid, Glycerin, Propylene Glycol, Cetereth-20, Carbomer, Aloe Vera, Disodium EDTA, Dimethicone, Petrolatum, Methylparaben, Triethanolamine, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Propylparaben, Beeswax, Sodium Carbomer, Phenonip, Triethanolamine.

SPL UNCLASSIFIED SECTION

New Hands Free Applicator

(Quad-5 Ball Roller)

Long Lasting and Soothing Deep Penetrating Action

Packaging

INGREDIENTS AND APPEARANCE

TRANSDERM-IQ 
capsaicin, lidocaine, menthol, methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70364-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0375 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	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	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
METHYLPARABEN (UNII: A2I8C7HI9T)
TROLAMINE (UNII: 9O3K93S3TK)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70364-001-04	113 g in 1 TUBE; Type 0: Not a Combination Product	04/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/17/2018

Labeler - Pocono Coated Products, LLC (362785771)

Establishment
Name	Address	ID/FEI	Business Operations
Pocono Coated Products, LLC		362785771	manufacture(70364-001)