Label: FACIAL CLEANSER- salicylic acid gel
- NDC Code(s): 55878-105-22, 55878-105-24, 55878-105-54
- 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 (0.5%)Close
WARNINGS FOR EXTERNAL USE ONLYClose
- INDICATIONS & USAGE
FOR THE TREATMENT OF ACNEClose
- 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 doctor.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
- WHEN USING
When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.Close
- DOSAGE & ADMINISTRATION
Wet your face and gently massage facial cleanser into skin for 10 - 15 seconds, avoiding contact with eyes. Thoroughly rinse your face with lukewarm water.
- Wash the entire affected area one to three times daily.
- 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, cocamidopropyl betaine, sodium olefin sulfonate, acrylate copolymer, triethanolamine, propylene glycol, polyquaternium-7, panthenol, phenoxyethanol, disodium EDTA, salvia officinalis (sage) leaf extract, citric acid, fragrance.Close
1-866-404-7656 or www.exposedskincare.comClose
- INGREDIENTS AND APPEARANCE
salicylic acid gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55878-105 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 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM C18 OLEFIN SULFONATE (UNII: Z6CI2A44YH) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) TROLAMINE (UNII: 9O3K93S3TK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55878-105-54 1 in 1 BOX 1 NDC:55878-105-24 120 mL in 1 BOTTLE 2 NDC:55878-105-22 60 mL in 1 BOTTLE 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)