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HSA Approval

GP-LIDOCAINE PATCH 5% W/W (700MG/PATCH)

SIN16833P

GP-LIDOCAINE PATCH 5% W/W (700MG/PATCH)

GP-LIDOCAINE PATCH 5% W/W (700MG/PATCH)

August 15, 2023

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGOLDPLUS UNIVERSAL PTE LTD
Licence HolderGOLDPLUS UNIVERSAL PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

PATCH

**DOSAGE AND ADMINISTRATION** **_Adults and elderly patients_** The painful area should be covered with the plaster once daily for up to 12 hours within a 24 hours period. Only the number of plasters that are needed for an effective treatment should be used. When needed, the plasters may be cut into smaller sizes with scissors prior to removal of the release liner. In total, not more than three plasters should be used at the same time. The plaster must be applied to intact, dry, non-irritated skin (after healing of the shingles). Each plaster must be worn no longer than 12 hours. The subsequent plaster-free interval must be at least 12 hours. The plaster must be applied to the skin immediately after removal from the sachet and following removal of the release liner from the gel surface. Hairs in the affected area must be cut off with a pair of scissors (not shaved). Treatment outcome should be re-evaluated after 2–4 weeks. If there has been no response to GP-LIDOCAINE PATCH 5% after this period or if any relieving effect can solely be related to the skin protective properties of the plaster, treatment must be discontinued as potential risks may outweigh benefits in this context. Treatment should be reassessed at regular intervals to decide whether the amount of plasters needed to cover the painful area can be reduced, or if the plaster free period can be extended. Use for patients under the age of 18 is not recommended because of the lack of data in this group.

TOPICAL

Medical Information

**INDICATION AND USAGE** GP-LIDOCAINE PATCH 5% is indicated for the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN).

**CONTRAINDICATIONS** GP-LIDOCAINE PATCH 5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. The plaster must not be applied to inflamed or injured skin, such as active herpes zoster lesions, atopic dermatitis or wounds.

N01BB02

lidocaine

Manufacturer Information

GOLDPLUS UNIVERSAL PTE LTD

Teh Seng Pharmaceutical Mfg. Co., Ltd. Third Factory

Active Ingredients

Lidocaine

700 mg/patch

Lidocaine

Documents

Package Inserts

GP-Lidocaine Patch 5 percent (700mg per patch) PI.pdf

Approved: November 7, 2023

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GP-LIDOCAINE PATCH 5% W/W (700MG/PATCH) - HSA Approval | MedPath