OTC Medication Information: TRANSDERM IQ

TRANSDERM IQ- menthol, unspecified form and lidocaine patch
TRANSDERM IQ- lidocaine and menthol, unspecified form 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.

Active ingredients:

Lidocaine HCL 4%

Menthol 4%

Purpose:

Topical Anesthetic

Uses:

For the temporary relief of pain

Warnings:

For external use

Do not use:

More than 1 patch on your body at a time or on cut, iritated or swollen skin.
On puncture wounds
For more than 1 week without consulting a doctor

When using this product:

Use only as directed. Read and follow all directions and warnings on this label.
Rare cases of serious burns have been reported with products of this type.
Do not apply to wounds or damaged, broken or irritated skin.
Do not allow contact with the eyes and mucous membranes.
Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
Do not use at the same time as other topical analgesics.
Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and ask a doctor if:

Condition worsens
Redness is present
Irritation developes
Symptoms persist for more than 7 days or clear up and occur again within a few days.
You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children and pets.

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

Directions:

Adults and children over 12 years:

Clean and dry the affected area.
Open pouch and remove one patch.
Remove the protective film from the patch and apply patch to the affected area.
Reseal pouch containing unused patches after each use.
Use 1 patch for up to 12 hours.

Children 12 years or younger:

Ask a doctor

Other Information:

Avoid storing product in direct sunlight Protect product from excessive mositure

Other Ingredients:

Acrylic Adhesive

148
(click image for full-size original)

166
(click image for full-size original)

TRANSDERM IQ transderm iq patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72189-148(NDC:70512-013)
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM 40 mg in 1 g
LIDOCAINE (LIDOCAINE) LIDOCAINE 40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ACRYLIC ACID
Product Characteristics
Color Score
Shape RECTANGLE Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72189-148-15 15 PATCH in 1 BOX contains a PATCH
1 1 g in 1 PATCH This package is contained within the BOX (72189-148-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 04/07/2021
TRANSDERM IQ transderm iq ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72189-166
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 40 mg in 1 g
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ACRYLIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72189-166-04 1 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/04/2021
Labeler — DIRECT RX (079254320)
Registrant — DIRECT RX (079254320)
Establishment
Name Address ID/FEI Operations
DIRECT RX 079254320 relabel (72189-148), manufacture (72189-166)

Revised: 06/2021 DIRECT RX

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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