Product Safety-Usage Information

Important Safety Information for Products:

Section 1: Contain 4% hydroquinone

CLINICAL PHARMACOLOGY: Topical application of hydroquinone produces a reversible depigmentation of skin by inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas, which may be prevented by the use of sunblocking agents or sunscreen agents.

INDICATIONS AND USAGE: For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

CONTRAINDICATIONS:People with prior history of sensitivity or allergic reaction to this product or any of its ingredients should not use it. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

WARNINGS:Avoid contact with eyes, nose, mouth, or lips. In case of accidental contact, patient should rinse eyes, nose, mouth, or lips with water and contact physician.

Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

PRECAUTIONS: Treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation, which does not preclude treatment.

Pregnancy Category C: Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used on pregnant women only when clearly indicated.

Nursing Mothers: It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.

Pediatric Usage: Safety and effectiveness in children below the age of 12 years have not been established.

Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

 

Section 2: Tretinoin

Active Ingredient:

TretinoinValid prescription required. 

INDICATIONS AND USAGE: Tretinoin Gel (Cream (0.1%, 0.05% and 0.025%) are used in the topical treatment of acne vulgaris.

Tretinoin is for use on the skin only. Do not get it in your mouth, eyes, vagina or the corners of your nose.

IMPORTANT SAFETY INFORMATION:

While using tretinoin, you should:

  • minimize exposure to the sun and to extreme cold or wind. Avoid sunlamps, tanning beds and ultraviolet light.
  • use a sunscreen with a SPF of at least 15, wear protective clothing and wide-brimmed hat
  • stop using tretinoin if you get a sunburn
  • avoid washing your skin too often, scrubbing the affected skin, or using other products with a drying effect, including other products containing tretinoin, unless recommended by your healthcare provider

Before using tretinoin, tell your healthcare provider if you:

  • are allergic to fish (gel only). Contact your healthcare provider if you develop itching or rash while using tretinoin gel.
  • have a skin condition called eczema
  • have a sunburn
  • are pregnant or breastfeeding, think you are pregnant, or plan to become pregnant or to breastfeed

What are the possible side effects of tretinoin?

  • skin dryness, burning, redness, excessive flaking or peeling. If you develop these symptoms your healthcare provider may tell you to stop using it for a while, decrease the number of applications, or stop using it completely.

Tell your healthcare provider about any side effect that bothers you or does not go away.

The safety and efficacy of Tretinoin have not been established in the treatment of patients younger than 10 years of age (Gel) or 12 years of age (Cream), or in pregnant or nursing women.