NDC 69313-635 Lidoflex

NDC Product Code 69313-635

NDC CODE: 69313-635

Proprietary Name: Lidoflex What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

69313 - Naimco, Inc. Dba Richmar, Inc.
- 69313-635 - Lidoflex

NDC 69313-635-20

Package Description: 25.8 mg in 1 PACKAGE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Lidoflex with NDC 69313-635 is a product labeled by Naimco, Inc. Dba Richmar, Inc.. The generic name of Lidoflex is . The product's dosage form is and is administered via form.

Labeler Name: Naimco, Inc. Dba Richmar, Inc.

Inactive Ingredient(s)

CROSPOVIDONE (UNII: 68401960MK)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
CROSPOVIDONE (UNII: 68401960MK)
CROSPOVIDONE (UNII: 68401960MK)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
CROSPOVIDONE (UNII: 68401960MK)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)

Product Labeler Information

Labeler Name: Naimco, Inc. Dba Richmar, Inc.
Labeler Code: 69313
Start Marketing Date: 09-01-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Lidoflex Product Label Images

Lidoflex Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Lidocaine 4% Patch
Warnings
Dosage & Administration
Inactive Ingredients
Indications & Usage
Otc - Keep Out Of Reach Of Children
Lidoflex 4% Lidocaine Pain Relieving Patch

Lidocaine 4% Patch

4% LIDOCAINE PAIN RELIEVING PATCH

4% LIDOCANIA PARCHE PARA ALIVIAR EL DOLOR

4% LIDOCAÏNE TIMBRE DE SOULAGEMENT DE LA DOULEUR

Drug Facts

Active ingredient (in each patch) Purpose

Lidocaine 4%...........................................................Topical anesthetic/analgesic/antipruritic
Inactive ingredients

Crospovidone, menthoxypropanediol, non-woven backing fabric, polyester film, non-latex rubber based adhesive*, vanillyl butyl ether
*adhesive not made with natural rubber latex.

Warnings

Do not apply over damaged, raw or blistered skin.

Do not apply excessive quantity of patches within 24 hour period.

Apply locally as needed; do not apply over large surface area of the body.

Avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water. If condition worsens, or if symptoms persist for more than 7 days

or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Do not use on the face or in large quantities, particularly over raw surfaces or blistered areas.

Do not use with a heating pad.

Stop use and ask a doctor if rash, itching or skin irritation develops.

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

Keep out of the reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Package is not child-resistant.

Dosage & Administration

Apply to affected area no more than three times per day.

Apply patch to the affected area and leave in place for up to 8 but no more than 12 hours.

Inactive Ingredients

Inactive ingredients

Crospovidone, menthoxypropanediol, non-woven backing fabric, polyester film, non-latex rubber based adhesive*, vanillyl butyl ether.
*adhesive not made with natural rubber latex.

Indications & Usage

Use

For the temporary relief of pain.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Package is not child-resistant.

Lidoflex 4% Lidocaine Pain Relieving Patch

CAUTIONS
Apply to affected area no more than three (3) times per day.

Apply patch to the affected area and leave in place for up to 8 but no more than 12 hours.

DISCARDING USED PATCH

Remove the patch and fold the adhesive sides together. Discard patch safely out of the reach of

children and pets.

Patent-Pending.

4% LIDOCAINE PAIN RELIEVING PATCH

4% LIDOCANIA PARCHE PARA ALIVIAR EL DOLOR

4% LIDOCAÏNE TIMBRE DE SOULAGEMENT DE LA DOULEUR

Drug Facts

Active ingredient (in each patch) Purpose

Lidocaine 4%...........................................................Topical anesthetic/analgesic/antipruritic

Use

For the temporary relief of pain.

Warnings

Do not apply over damaged, raw or blistered skin.

Do not apply excessive quantity of patches within 24 hour period.

Apply locally as needed; do not apply over large surface area of the body.

Avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water. If condition worsens, or if symptoms persist for more than 7 days

or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Do not use on the face or in large quantities, particularly over raw surfaces or blistered areas.

Do not use with a heating pad.

Stop use and ask a doctor if rash, itching or skin irritation develops.

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

Keep out of the reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Package is not child-resistant.

Directions

Adults and children 12 years and older:

For best results:

• Remove excess hair at treatment site.

• Clean area thoroughly with soap and water or alcohol wipe, removing all oils, lotions and dirt.

• Do not use oils, lotions or powders in treatment area prior to application.

• For best adhesion, apply as directed to the affected area a minimum of 1 hour prior to getting skin wet.

• Open pouch and remove patch.

• Remove protective liner and apply to skin.

• Discard the liner.

• Apply patch to the affected area, pressing down firmly from the center outwards to ensure adhesion and minimize folds.

Continue to press down firmly until the patch has secure contact with the skin.

• Apply to affected area no more than three (3) times per day.

• Leave in place for up to 8 but no more than 12 hours.

• For maximum pain relief, choose the appropriate size of patch based on the size of the treatment area and the body area to be treated.

Example–use a LidoFlex back patch for back pain relief, use a LidoFlex Flex Strip for ankle or forearm pain relief.

Patches may be cut into smaller sizes as needed to treat affected area. Before removing the clear protective liner, cut patch to the desired size. Once cut, remove the clear protective liner. Remaining patch material must be sealed to be effective. Discard all unused portions of the patch safely out of the reach of children and pets.

Children under 12 years of age:

Ask a doctor before use.

Other information

Some individuals may not experience pain relief until several hours after applying the patch.

Store in a cool, dry place. Protect from freezing and excessive heat. Store at 68-77°F (20-25°C).

Excursions permitted between 59 and 86°F (15 and 30°C).

Use cleaning pads provided to remove any residual adhesive sticking to the skin.

Inactive ingredients

Crospovidone, menthoxypropanediol, non-woven backing fabric, polyester film, non-latex rubber based adhesive*, vanillyl butyl ether.

*adhesive not made with natural rubber latex.
Package not child-resistant. Keep out of the reach of children.

To report SUSPECTED ADVERSE REACTIONS, contact Richmar Regulatory at 1.888.549.4945 or 1.423.648.7730
www.lidoflex.com