TRANSDERM-IQ- transderm-iq ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM), MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Available from:
Direct_Rx
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical analgesic Temporary relief of minor aches and pains of muscles and joints associated with:• simple backache • arthritis • muscle strains • sprains • bruises
Authorization status:
OTC monograph not final
Authorization number:
61919-851-04

TRANSDERM-IQ- transderm-iq ointment

Direct_Rx

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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TRANSDERM-IQ

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

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.

New Hands Free Applicator

(Quad-5 Ball Roller)

Long Lasting and Soothing Deep Penetrating Action

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

Topical analgesic

Capsaicin 0.0375%

Lidocaine 4%

Menthol 10%

Methyl Salicylate 20%

Temporary relief of minor aches and pains of muscles and joints associated with: simple backache

arthritis muscle strains sprains bruises

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.

TRANSDERM-IQ

transderm-iq ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 19 19 -8 51(NDC:70 36 4-0 0 1)

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAPSAICIN (UNII: S0 7O44R1ZM) (CAPSAICIN - UNII:S0 7O44R1ZM)

CAPSAICIN

0 .0 375 g

in 10 0 g

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL, UNSPECIFIED FORM

- UNII:L7T10 EIP3A)

MENTHOL, UNSPECIFIED

FORM

10 g in 10 0 g

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

20 g in 10 0 g

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

4 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GLYCERIN (UNII: PDC6 A3C0 OX)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

CARBO MER HO MO PO LYMER TYPE B ( ALLYL SUCRO SE CRO SSLINKED) (UNII: Z135WT9 20 8 )

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

PO LYO XYL 2 0 CETO STEARYL ETHER (UNII: YRC528 SWUY)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

Dire ct_Rx

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

MINERAL O IL (UNII: T5L8 T28 FGP)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PETRO LATUM (UNII: 4T6 H12BN9 U)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -8 51-0 4

113 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 7/25/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 7/25/20 19

Labeler -

Direct_Rx (079254320)

Registrant -

Direct_Rx (079254320)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dire c t_Rx

0 79 254320

re pa c k(6 19 19 -8 51)

Revised: 9/2019

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