Label: REFINE COMPLEXION CLEARING PADS- salicylic acid swab
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Contains inactivated NDC Code(s)
NDC Code(s): 70911-110-11, 70911-110-12 - Packager: SCHWEIGER DERMATOLOGY GROUP
- 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 September 15, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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Warnings
For External use only.
- When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
Keep out of reach of children - When using this product, rinse immediately with water if it gets in eyes.
- If swallowed, consult a physician or poison control center.
- When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
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Directions
- Clean the skin thoroughly before applying this product.
- Cover the entire affected area with a thin layer 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 the application to once a day or every other day.
- If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
- Additional Information
- Inactive ingredients
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 Pad Carton
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INGREDIENTS AND APPEARANCE
REFINE COMPLEXION CLEARING PADS
salicylic acid swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70911-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCOLIC ACID (UNII: 0WT12SX38S) MANDELIC ACID (UNII: NH496X0UJX) POLYSORBATE 20 (UNII: 7T1F30V5YH) calendula officinalis flowering top (UNII: 18E7415PXQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CHAMOMILE (UNII: FGL3685T2X) ALOE VERA LEAF (UNII: ZY81Z83H0X) AMMONIA (UNII: 5138Q19F1X) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Product Characteristics Color WHITE Score Shape ROUND Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70911-110-12 1 in 1 CARTON 01/01/2017 1 NDC:70911-110-11 60 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 01/01/2017 Labeler - SCHWEIGER DERMATOLOGY GROUP (007492566)
