Label: SALICYLIC ACID- wart remover gel pen gel
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-185-04 - Packager: CVS Pharmacy
- 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 July 16, 2021
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- Active ingredient
- Purpose
- Use
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Warnings
For external use only.
Do not use
- if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist
- on moles, birthmarks and warts with hair growing from them
- on mucous membranes such as nose, anus, genitals and lips
- on irritated, infected or reddened skin
- on genital warts and warts on the face
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Directions
- after washing affected area
- may soak wart in warm water for 5 minutes
- dry area thoroughly
- remove cap from pen
- remove insert pin from the tip and discard
- twist and click pen until wart remover gel is dispensed onto the tip of the applicator. Initial use will require several rotations for the gel to load
- apply a small amount at a to sufficiently cover each wart
- let dry
- repeat this procedure once or twice daily (until wart is removed) for up to 12 weeks
- for storage, ensure applicator is free of excess gel before placing the cap back on
- keep outer package for complete Drug Facts information
- Other information
- Inactive ingredients
- Questions?
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INGREDIENTS AND APPEARANCE
SALICYLIC ACID
wart remover gel pen gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-185 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.21 g in 1.25 g Inactive Ingredients Ingredient Name Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) ALCOHOL (UNII: 3K9958V90M) ETHYL ACETATE (UNII: 76845O8NMZ) HYPOPHOSPHOROUS ACID (UNII: 8B1RL9B4ZJ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PYROXYLIN (UNII: KYR8BR2X6O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-185-04 1.25 g in 1 APPLICATOR; Type 0: Not a Combination Product 10/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358B 10/01/2014 Labeler - CVS Pharmacy (062312574)