ACNE MEDICATION 10
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
For external use only
When using this product
- apply to affected ares only
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips and mouth
- this product may bleach hair or dyed fabrics
- with other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. Only one medication should be used unlee directed by a physician
- skin irritaion may occur characterized by redness, burning, itching, peeling or possible swelling
- clean the skin thoroughly before applying
- cover the entire affected area with a thin layer 1 to 3 times daily
- because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application ot once a day or every other day.
- if going outside, use a sunscreen. Allow benzoyl peroxide to dry, then follow directions in the sunscreen labeling.
- Sensitivity Test for New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
- store at room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F)
- Lot number & expiration date: See box or crimp of the tube
|ACNE MEDICATION 10
benzoyl peroxide gel
|Labeler - Rugby Laboratories (191427277)|
Document Id: 03b94e6c-f864-48ad-94c1-f08ddc2c2de0
Set id: 18e83482-f792-49c4-9faa-f26521832cf2
Effective Time: 20130115