Label: CLEAR PORE SERUM- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 55878-103-11, 55878-103-12, 55878-103-52 - Packager: Halogent, LLC (DBA Exposed Skin Care)
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated March 13, 2013
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- PURPOSE
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR/PHARMACIST
- WHEN USING
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DOSAGE & ADMINISTRATION
Directions
Gently apply a small amount of serum to affected area using your bare hands. Avoid contact with eyes.
- Cleanse the skin thoroughly before applying medication
- 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 or peeling occurs, reduce application to once a day or every other day.
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INACTIVE INGREDIENT
Inactive Ingredients
Water, hamamelis virginiana (witch hazel) distillate, glycerin, propylene glycol, peg 120 methyl glucose dioleate, polyquaternium-37, hydrogenated polydecene, tricedeth-6, spiraea ulmaria (meadowsweet) extract, glycyrrhiza glabra (licorice) root extract, ocimum basilicum extract , camellia sinensis (green tea) leaf extract, panthenol, phenoxyethanol, fragrance.
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- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEAR PORE SERUM
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55878-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) TRIDECETH-6 (UNII: 3T5PCR2H0C) FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) LICORICE (UNII: 61ZBX54883) OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2) CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55878-103-52 1 in 1 BOX 1 NDC:55878-103-12 50 mL in 1 TUBE 2 NDC:55878-103-11 26 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/07/2013 Labeler - Halogent, LLC (DBA Exposed Skin Care) (790961697)