Label: CLEARASIL ULTRA RAPID ACTION TREATMENT- salicylic acid lotion
- NDC Code(s): 63824-314-01
- Packager: Reckitt Benckiser LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Salicylic acid 2%Close
for the treatment of acneClose
For external use only
When using this product
- avoid contact with the eyes. If product gets into the eyes rinse thoroughly with water.
- using other topical acne medications at the same time or immediately following the use of this product, may increase dryness or irritation of the skin. If this occurs, only one acne medication should be used unless directed by your doctor.
- limit use to the face and neck, chest and back
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
- cleanse the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one 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
- Other information
- store in a cool, dry place
- Inactive ingredients
water, butylene glycol, octyldodecanol, steareth-2, cetyl alcohol, steareth-21, dimethicone, polyacrylamide, glycerin, C13-14 isoparaffin, sodium hydroxide, xanthan gum, magnesium aluminum silicate, laureth-7, fragrance, Lavandula stoechas extract, Helichrysum italicum extract, Cistus monspeliensis extract, titanium dioxideClose
call 1-866-25-CLEAR (1-866-252-5327). You may also report side effects to this phone number.Close
- SPL UNCLASSIFIED SECTION
Reckitt Benckiser LLC
Parsippany, NJ 07054-0224
- PRINCIPAL DISPLAY PANEL - 118 mL Tube Label
Face, Chest & Back
Salicylic Acid 2% Acne Medication
pimple size in
as fast as
With Acceladerm® Technology
4 FL. OZ. (118 mL)
- INGREDIENTS AND APPEARANCE
CLEARASIL ULTRA RAPID ACTION TREATMENT
salicylic acid lotion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-314 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 2 g in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) butylene glycol (UNII: 3XUS85K0RA) octyldodecanol (UNII: 461N1O614Y) cetyl alcohol (UNII: 936JST6JCN) steareth-21 (UNII: 53J3F32P58) dimethicone (UNII: 92RU3N3Y1O) glycerin (UNII: PDC6A3C0OX) C13-14 isoparaffin (UNII: E4F12ROE70) sodium hydroxide (UNII: 55X04QC32I) xanthan gum (UNII: TTV12P4NEE) magnesium aluminum silicate (UNII: 6M3P64V0NC) laureth-7 (UNII: Z95S6G8201) Helichrysum Italicum Flower (UNII: P62Y550X24) titanium dioxide (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-314-01 118 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 11/08/2013 Labeler - Reckitt Benckiser LLC (094405024)