Melatoning Cream

Gradual bleaching of skin with the following excessive pigmentation: chloasma, melanosis (melasma), freckles, senile lentigines (age spots), and other excessive melanin pigmentation in unwanted areas

Apply to the affected area 1–2 times a day (in the morning and before bedtime), at a strength of 2% as hydroquinone.

1. Warnings

1) When using this medicine, blocking exposure to sunlight is more important than anything else. Melanin production can continue even with minimal exposure to sunlight. During and after use of this medicine, take particular care not to expose the treated area to sunlight, in order to protect the bleached skin and prevent recurrence, and use a sunscreen or wear clothing that protects against sunlight. Cases of adverse effects, such as discoloration of the skin after the treated area was exposed to sunlight, have been reported.

2) Mutagenicity and carcinogenicity of hydroquinone have been observed in animal studies (high-dose oral administration); therefore, adjust the duration of administration appropriately according to the therapeutic effect, and do not use it for a long period.

2. Do not administer to the following patients.

1) Patients with hypersensitivity to this medicine or its ingredients or a history thereof, or a history of allergic reactions

2) Pregnant women or women who may be pregnant

3) Children aged 12 years or younger

4) Patients with renal impairment

3. Administer with caution to the following patients.

This medicine contains sodium metabisulfite, so it can cause allergic reactions such as sulfite anaphylaxis and, in some susceptible patients, asthma attacks that may be life-threatening or milder. The overall prevalence of sulfite sensitivity in the general population is unknown but appears to be low, and sulfite sensitivity has been found to occur more frequently in asthmatic than in non-asthmatic people.

4. Adverse reactions

Hypersensitivity reactions such as contact dermatitis may occasionally occur; in such cases, stop administration and consult a doctor or pharmacist.

5. General precautions

1) Before using this medicine, test for skin hypersensitivity by applying a small amount to the skin and observing it for 24 hours. The medicine may be used if only minor redness occurs, but do not use it if itching, blisters or excessive inflammation appear.

2) If the symptoms do not improve after about 2 months of use, stop using it.

3) Use this medicine only for depigmentation of the skin; do not use it to block sunlight or to prevent sunburn.

4) If this medicine is taken by mouth, consult a doctor or pharmacist.

6. Use in pregnant and breastfeeding women

1) Do not administer to pregnant women or women who may be pregnant (safety has not been established).

2) It is not known whether this medicine is absorbed and excreted into breast milk; administer with caution to breastfeeding women.

7. Use in children

Do not administer to children aged 12 years or younger (safety and efficacy have not been established).

8. Treatment of overdose

No systemic effects from topical administration of this medicine have been reported. However, its absorption is not clearly known, and transient redness of the skin and a mild burning sensation, for which a relationship with this medicine could not be ruled out, occurred in some patients; therefore, keep the treated area small (the treated area should not exceed 10% of the total skin surface).

9. Precautions for application

1) This medicine is for external use only.

2) Take care not to let it come into contact with the eyes and mucous membranes.

10. Storage and handling precautions

1) Keep out of the reach of children.

2) Transferring the medicine to another container may cause accidents or is undesirable for maintaining its quality; take care to avoid this.

11. Other

Ochronosis and colloid milium have been reported with chronic use (about 8 years) of 5% hydroquinone cream.