Shu Yang Ointment

I. Do not use if you have any of the following conditions

1. Have previously had an allergic reaction to any ingredient in this medicine.
2. Children under 2 years of age.
3. Individuals who have had an allergic or hypersensitive reaction to aspirin or salicylates.

II. Consult a doctor before use if you have any of the following conditions

1. Children under 3 years of age.
2. Deep skin tissue infections.
3. Pregnant women at 20 weeks of gestation or more. (See [Warnings])

III. Consult a doctor, pharmacist, or dispensing pharmacist before use if you have any of the following conditions

1. Children, pregnant women, women who may be pregnant, and breastfeeding women.
2. Use on the face.
3. Pregnant women at less than 20 weeks of gestation and women who may be pregnant. (See [Warnings])

IV. Other precautions for use

1. Keep out of children’s reach to prevent accidental ingestion.
2. Avoid direct sunlight.
3. Do not exceed the recommended amount or frequency of use.
4. If the application site or surrounding area is dirty, clean it before applying the medicine.
5. Wash your hands thoroughly before and after use.
6. This medicine is for external use only. Do not take internally. Do not apply around the eyes, on mucous membranes (such as the mouth, nasal cavity, vagina, scrotum, or vulva), or on ulcerated, cracked, or severely injured skin.
7. Be careful to avoid contact with the eyes. If accidental contact occurs, rinse immediately with water or warm water and see an ophthalmologist right away.
8. After application, keep the application site ventilated and do not seal it, to avoid increasing the risk of side effects.
9. Do not use this medicine continuously for more than 7 days.
10. Avoid contact with clothing, plastic items, wood, or metal.
11. Do not use over a large area for a long period of time (as a reference, no larger than the area of the user’s two palms), to avoid causing salicylate poisoning symptoms such as difficulty breathing, sweating, elevated body temperature, flushing, persistent tinnitus, or severe or persistent headache. Consult a doctor or pharmacist before use.
12. After use, close the cap tightly to prevent the medicinal odor from escaping.

V. Warnings

1. If any of the following side effects occur after use, stop use immediately and consult a doctor, pharmacist, or dispensing pharmacist, bringing this package insert with you:
   • Skin: redness, itching, stinging sensation.
   • Other: salicylate effects (tinnitus, dizziness, nausea, vomiting, etc.)
2. If any of the following symptoms occur after use, stop use immediately and seek medical attention
   • Any other discomfort not listed above occurs.
   • No improvement or worsening of condition after 7 days of use.
3. Nonsteroidal anti-inflammatory drugs (NSAIDs) may affect pregnancy and/or embryonic/fetal development. Use during 30 weeks of gestation or more may cause premature closure of the fetal ductus arteriosus and pulmonary hypertension; use during 20 weeks of gestation or more may cause fetal renal impairment, oligohydramnios, or even neonatal kidney damage; use in early pregnancy may increase the risk of miscarriage and cardiac malformation. Please follow the recommendations below:
   • Pregnant women at 30 weeks of gestation or more should avoid use.
   • Pregnant women at 20 to 30 weeks of gestation should have a doctor confirm the necessity of use before treatment, and use the lowest effective dose for the shortest duration; if treatment exceeds 48 hours, ultrasound monitoring of amniotic fluid may be required.
   • Pregnant women at less than 20 weeks of gestation and women who may be pregnant should consult a doctor, pharmacist, or dispensing pharmacist before use.