Label: PROACTIV REVITALIZING TONER COMBINATION THERAPY ACNE TREATMENT- salicylic acid liquid
- NDC Code(s): 11410-019-10, 11410-019-20, 11410-019-40, 11410-019-70
- Packager: Guthy-Renker LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: 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.
Updated April 6, 2010
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
Salicylic Acid 2%Close
For the management of acneClose
For external use only
When using this product
- using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- Cleanse the skin thoroughly before applying medication.
- Using a cotton ball or pad, cover the entire affected area 1 to 3 times daily.
- Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- Inactive Ingredients
water (aqua), butylene glycol, hamamelis virginiana (witch hazel) water, glycolic acid, sodium hydroxide, portulaca oleracea extract, polysorbate 20, ethylhexylglycerin, disodium EDTA, phenoxyethanol, sodium benzoate, fragrance (parfum)Close
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
Rodan & Fields
salicylic acid acne treatment
1 FL. OZ. 30 mL
- INGREDIENTS AND APPEARANCE
PROACTIV REVITALIZING TONER COMBINATION THERAPY ACNE TREATMENT
salicylic acid liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-019 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 mg in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-019-10 30 mL in 1 BOTTLE 2 NDC:11410-019-20 60 mL in 1 BOTTLE 3 NDC:11410-019-40 120 mL in 1 BOTTLE 4 NDC:11410-019-70 180 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 08/01/2010 Labeler - Guthy-Renker LLC (608315453)