Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
PATCH, EXTENDED RELEASE
**Directions:** **Adults and children 15 years of age and over:** Clean and dry affected area. Remove patch from backing film and apply to skin. Apply 1 patch to the affected area and leave in place for up to 24 hours. Do not use more than 2 patches per day. **Children under 15 years of age:** Do not use.
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 because of the risk of masking underlying skin infections. - 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
Hisamitsu Pharmaceutical Co., Inc. Utsunomiya Factory
Active Ingredients
Documents
Patient Information Leaflets
Inner Labels_3patches per pouch PIL.pdf
Approved: July 7, 2022