Label: CLEAR PORE SERUM- salicylic acid gel
- NDC Code(s): 55878-103-11, 55878-103-12, 55878-103-52
- Packager: Halogent, LLC (DBA Exposed Skin Care)
- 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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- ACTIVE INGREDIENT
SALICYLIC ACID (1.0%)Close
- INDICATIONS & USAGE
FOR THE TREATMENT OF ACNEClose
WARNINGS FOR EXTERNAL USE ONLYClose
- ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctorClose
- WHEN USING
When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.Close
- DOSAGE & ADMINISTRATION
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.
- INACTIVE INGREDIENT
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.Close
- KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN, IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.Close
- INGREDIENTS AND APPEARANCE
CLEAR PORE SERUM
salicylic acid gel
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55878-103 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK GLYCERIN PROPYLENE GLYCOL PEG-120 METHYL GLUCOSE DIOLEATE POLYQUATERNIUM-37 (10000 MPA.S) HYDROGENATED POLYDECENE (550 MW) TRIDECETH-6 FILIPENDULA ULMARIA FLOWER LICORICE OCIMUM BASILICUM FLOWERING TOP CAMELLIA SINENSIS WHOLE PANTHENOL PHENOXYETHANOL 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)