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HSA Approval

SALONPAS DICLOFENAC GEL 1%

SIN16418P

SALONPAS DICLOFENAC GEL 1%

SALONPAS DICLOFENAC GEL 1%

January 17, 2022

HISAMITSU PHARMACEUTICAL CO., INC. SINGAPORE BRANCH

HISAMITSU PHARMACEUTICAL CO., INC. SINGAPORE BRANCH

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantHISAMITSU PHARMACEUTICAL CO., INC. SINGAPORE BRANCH
Licence HolderHISAMITSU PHARMACEUTICAL CO., INC. SINGAPORE BRANCH

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
General Sale List
HSA Singapore Classification

Formulation Information

GEL

**Directions:** **Adults and children 15 years of age and over:** Clean and dry affected area. Apply to affected area not more than 3 to 4 times daily. Do not use more than 50g per week. **Children under 15 years of age:** Do not use. **What you should do if you miss a dose:** Do not worry, apply Salonpas® Diclofenac Gel 1% as soon as you remember and then continue with the normal dose. Do NOT use a double application to make up for forgotten individual application.

TOPICAL

Medical Information

**Indications:** For relief of aches, pains and inflammation associated with: - muscle pain - stiff shoulder - backache - bruises - sprains - strains - joint pain - tendons inflammation - elbow pain

**Contraindications:** **Do not use** - on wounds or damaged skin. - on eyes, mucous membranes or rashes. - on suppurating area. This product may mask skin infection. - if you are allergic to any ingredients of this product. - if you are pregnant. - if you are with a history of asthma. - on children under 15 years of age.

M02AA15

diclofenac

Manufacturer Information

HISAMITSU PHARMACEUTICAL CO., INC. SINGAPORE BRANCH

CMIC CMO Co., Ltd. Toyama Plant

Active Ingredients

Diclofenac Sodium

1g/100g

Diclofenac

Documents

Patient Information Leaflets

Patient Information Leaflet.pdf

Approved: January 17, 2022

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SALONPAS DICLOFENAC GEL 1% - HSA Approval | MedPath