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HSA Approval

CLINDOXYL Once Daily Gel

SIN13332P

CLINDOXYL Once Daily Gel

CLINDOXYL Once Daily Gel

August 7, 2007

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGLAXOSMITHKLINE PTE LTD
Licence HolderGLAXOSMITHKLINE PTE LTD

Product Classification

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

Formulation Information

GEL

**Dosage and Administration** **Adults and Adolescents** Clindoxyl® Once Daily Gel is for topical use only. Clindoxyl® Once Daily Gel should be applied in a thin film over entire affected area once daily after washing gently with a mild cleanser and fully drying. If the gel does not rub into the skin easily, too much is being applied. Hands should be washed after application. Patients may also use a moisturiser as needed. Two to five weeks of treatment may be required before a therapeutic effect is observed ( _see Clinical Studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The safety and efficacy of clindamycin/benzoyl peroxide have not been studied beyond 12 weeks in acne vulgaris clinical trials. The prescriber should evaluate the benefit of continuing treatment beyond 12 weeks of uninterrupted use. **Children** The safety and efficacy of Clindoxyl® Once Daily Gel have not been established in children less than 12 years of age, therefore clindamycin/benzoyl peroxide is not recommended for use in this population. **Elderly** There are no specific recommendations for use in the elderly.

TOPICAL

Medical Information

**Indications** Clindoxyl® Once Daily Gel is indicated for the topical treatment of mild to moderate acne vulgaris. Clindoxyl® Once Daily Gel has not been demonstrated to have any additional benefit when compared to benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.

**Contraindications** Clindoxyl® Once Daily Gel is contraindicated in: - patients who have demonstrated hypersensitivity to lincomycin, clindamycin, benzoyl peroxide or any components of the formulation. - patients with, or with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis (including pseudomembranous colitis).

D10AF51

clindamycin, combinations

Manufacturer Information

GLAXOSMITHKLINE PTE LTD

Stiefel Laboratories (Ireland) Ltd

Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)

Active Ingredients

Clindamycin Phosphate

1.28% w/w

Clindamycin

Benzoyl Peroxide Hydrous

6.67% w/w

Benzoyl peroxide

Documents

Package Inserts

CLINDOXYL Once Daily Gel PI.pdf

Approved: March 5, 2013

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CLINDOXYL Once Daily Gel - HSA Approval | MedPath