Label: ANTI-BLEMISH- salicylic acid disc
- NDC Code(s): 63550-154-90
- Packager: Kamins Dermatologics Inc.
- 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 December 1, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
A sophisticated anti-blemish pad formulated with pharmaceutical grade, proven acne-fighting ingredients to help clear blemishes and blackheads as well as prevent future breakouts. This hydrating, innovative and gentle formula will improve skin texture and clarity, as well as moisturize to help prevent skin from over-drying or becoming flaky. Ideal for both adolescent and adult acne.
Uses
■ helps dissolve excess oil (sebum)
■ helps reduce bacteria that may cause breakouts
■ helps penetrate pores to control acne blemishes
■ helps prevent new blemishes -
WARNINGS
Warnings
For external use only.
Avoid contact with eyes when using this product. If contact occurs, rinse abundantly with water to remove.
Discontinue use in case of excessive skin irritation or if condition does not improve. If irritation persists, consult a health care practitioner.
Using other topical acne products at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a health care practitioner.
Keep out of children’s reach. Do not use if security seal is missing or broken. Close tightly after use. Keep product in original jar.
Other information
Store at room temperature 15-30°C (59-86°F). -
DOSAGE & ADMINISTRATION
Directions
■ Use the pad to wipe the entire affected area after cleansing and toning face. Do not leave pad on skin for an extended period of time.
■ Begin with one application daily, gradually increasing up to two to three times daily or as directed by a health care practitioner.
■ Application should be reduced if severe dryness occurs. When using this product, it is always recommended to apply a sunscreen before sun exposure. - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI-BLEMISH
salicylic acid discProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63550-154 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) OCTOXYNOL 9 (UNII: 7JPC6Y25QS) MAPLE SYRUP (UNII: 75UOH57984) SODIUM THIOSULFATE (UNII: HX1032V43M) SODIUM HYDROXIDE (UNII: 55X04QC32I) ZINC SULFATE (UNII: 89DS0H96TB) PEPPERMINT OIL (UNII: AV092KU4JH) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63550-154-90 35 in 1 BOX; Type 0: Not a Combination Product 08/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/01/2010 Labeler - Kamins Dermatologics Inc. (254050784) Establishment Name Address ID/FEI Business Operations Odan Laboratories Ltd 208585604 manufacture(63550-154)
