Label: RITE AID MAXIMUM STRENGTH FOOT CARE ANTI-FUNGAL PEN- undecylenic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-9650-1, 11822-9650-2 - Packager: Rite Aid
- 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 January 11, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- ASK DOCTOR
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
- read all warnings and directions
- use only as directed
- clean the affected area with soap and water and dry thoroughly
- remove cap from pen
- twist the base of the pen, with brush pointing downward, until product dispenses
- apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
- for athlete’s foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
- for athlete’s foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor
- intended for use by normally healthy adults only
- persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor
- supervise children in the use of this product
- this product is not effective on the scalp or nails
- Other Information
- Inactive Ingredients
- Questions or Comments?
- Image of Box and Label
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INGREDIENTS AND APPEARANCE
RITE AID MAXIMUM STRENGTH FOOT CARE ANTI-FUNGAL PEN
undecylenic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-9650 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 250 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-9650-2 1 in 1 BOX 12/10/2013 1 NDC:11822-9650-1 1.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/10/2013 Labeler - Rite Aid (014578892) Establishment Name Address ID/FEI Business Operations Dhaliwal Laboratories,LLC 016754201 manufacture(11822-9650)
LabelRiteAidAntiFungalPen.jpg
