Label: BLISTEX STRIDEX SPOT AND T-ZONE ACNE CLEARGEL- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10157-2101-1 - Packager: Blistex Inc
- Category: HUMAN OTC DRUG LABEL
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 November 24, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Allergy alert:
do not use this product if you have a known allergy to salicylic acid
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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 application to once a day or every other day
- keep away from eyes, lips and other mucous membranes
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 28.35 g Jar Carton
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INGREDIENTS AND APPEARANCE
BLISTEX STRIDEX SPOT AND T-ZONE ACNE CLEARGEL
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-2101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 2 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE SODIUM (UNII: MP1J8420LU) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALOE VERA LEAF (UNII: ZY81Z83H0X) MALEIC ANHYDRIDE (UNII: V5877ZJZ25) 1,9-DECADIENE (UNII: 2KWZ01G244) METHYL VINYL ETHER (UNII: G2OHX46576) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10157-2101-1 1 in 1 CARTON 1 28.35 g 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 01/04/2016 Labeler - Blistex Inc (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc 005126354 MANUFACTURE(10157-2101)