Label: CLEARASIL ULTRA OVERNIGHT WASH- salicylic acid solution
- NDC Code(s): 63824-306-88
- 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.
Updated October 4, 2012
If you are a consumer or patient please visit this version.
- 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.
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
- limit use to the face and neck
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- use as part of your night time regimen
- wet face
- dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area
- rinse thoroughly with warm water and pat dry
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness occurs, reduce application to once a day or every other day
- Other information
- store in a cool, dry place
- do not store in direct sunlight
- Inactive ingredients
water, glycerin, sodium laureth sulfate, coco-glucoside, cocamidopropyl betaine, glycol distearate, PEG-200 hydrogenated glyceryl palmate, laureth-4, sodium chloride, PEG-7 glyceryl cocoate, polyquaternium-43, fragrance, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract, sodium hydroxide, formic acid, phenoxyethanol, sodium benzoate, D&C red no. 33, FD&C blue no. 1Close
Call 1-866-25-CLEAR (1-866-252-5327). You may also report side effects to this phone number.Close
- SPL UNCLASSIFIED SECTION
Distributed by: Reckitt BenckiserClose
LLC Parsippany, NJ 07054-0224
Made in France
- PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label
Salicylic Acid 2% Acne Medication
6.78 FL. OZ. (200 mL)
- INGREDIENTS AND APPEARANCE
CLEARASIL ULTRA OVERNIGHT WASH
salicylic acid solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-306 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) glycerin (UNII: PDC6A3C0OX) sodium laureth sulfate (UNII: BPV390UAP0) coco glucoside (UNII: ICS790225B) cocamidopropyl betaine (UNII: 5OCF3O11KX) glycol distearate (UNII: 13W7MDN21W) laureth-4 (UNII: 6HQ855798J) sodium chloride (UNII: 451W47IQ8X) PEG-7 glyceryl cocoate (UNII: VNX7251543) helichrysum italicum flower (UNII: P62Y550X24) sodium hydroxide (UNII: 55X04QC32I) formic acid (UNII: 0YIW783RG1) phenoxyethanol (UNII: HIE492ZZ3T) sodium benzoate (UNII: OJ245FE5EU) D&C red no. 33 (UNII: 9DBA0SBB0L) FD&C blue no. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-306-88 200 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 09/28/2012 Labeler - Reckitt Benckiser LLC (094405024)