Label: CLEARING TONIC- salicylic acid liquid
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Contains inactivated NDC Code(s)
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
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
- WARNINGS
- INDICATIONS & USAGE
- ASK DOCTOR/PHARMACIST
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
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DOSAGE & ADMINISTRATION
Directions
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.
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INACTIVE INGREDIENT
Inactive Ingredients
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.
- QUESTIONS
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INGREDIENTS AND APPEARANCE
CLEARING TONIC
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55878-104 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) 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)
