Label: CLEARING TONIC- salicylic acid liquid
- NDC Code(s): 55878-104-22, 55878-104-24, 55878-104-54
- 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 (1%)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
Gently apply a small amount of Clearing Tonic 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, glycolic acid, propylene glycol, azelaic acid, hamamelis virginiana (witch hazel) distillate, dimethylethanolamine, phenoxyethanol, sodium hydroxide, camellia sinensis (green tea) leaf extract, passiflora edulis (passion) flower extract, aloe barbadensis leaf extract, salvia officinalis (sage) leaf extract, fragrance.Close
- INGREDIENTS AND APPEARANCE
salicylic acid liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55878-104 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 1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCOLIC ACID (UNII: 0WT12SX38S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) AZELAIC ACID (UNII: F2VW3D43YT) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) DEANOL (UNII: 2N6K9DRA24) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ) 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) PASSIFLORA EDULIS FLOWER (UNII: SY49TH8VUA) ALOE VERA LEAF (UNII: ZY81Z83H0X) SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55878-104-54 1 in 1 BOX 1 NDC:55878-104-24 120 mL in 1 BOTTLE 2 NDC:55878-104-22 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)