TRANSDERM IQ by Direct_Rx / PURE SOURCE, LLC Transderm IQ

Drug Details [pdf]

TRANSDERM IQ- transderm iq ointment
Direct_Rx

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Transderm IQ

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

72189-0166-04

TRANSDERM IQ
transderm iq ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72189-166
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
DIMETHICONE 20 (UNII: H8YMB5QY0D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
INULIN (UNII: JOS53KRJ01)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
CAPSAICIN (UNII: S07O44R1ZM)
CETYL ALCOHOL (UNII: 936JST6JCN)
CINNAMON LEAF OIL (UNII: S92U8SQ71V)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALLANTOIN (UNII: 344S277G0Z)
2,4,5-T-TRIETHYLAMMONIUM (UNII: R53J3NE5QH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 72189-166-04	1 g in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2021	10/16/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	06/04/2021	10/16/2023

Labeler - Direct_Rx (079254320)

Registrant - Direct_Rx (079254320)

Name	Address	ID/FEI	Business Operations
Establishment
PURE SOURCE, LLC		080354456	manufacture(72189-166)

Revised: 10/2023

Document Id: 07d96c85-9cb8-f4f1-e063-6394a90a5b39

Set id: bf62730a-fec9-1b52-e053-2995a90ab979

Version: 8

Effective Time: 20231016