RITE AID MAXIMUM STRENGTH FOOT CARE ANTI-FUNGAL PEN- undecylenic acid liquid

RIte Aid by

Drug Labeling and Warnings

RIte Aid by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Dhaliwal Laboratories,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Undecylenic Acid 25%

Purpose

Anti-fungal

Uses

For the cure of most:

• ringworm (tinea corporis)
• athlete’s foot (tinea pedis)

For the relief of:

• itching
• scaling
• cracking
• burning
• redness
• soreness
• irritation and discomforts which may accompany these conditions

Warnings

For external use only

ASK DOCTOR

Ask a doctor before use on children under 2 years of age

DO NOT USE

Do not use on diaper rash

WHEN USING

When using this product avoid contact with the eyes

STOP USE

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

• Store at 15°-30C° (59°-86°F)
• Keep cap on pen when not in use

Inactive Ingredients

Isopropyl Palmitate, Propylparaben

Questions or Comments?

1-800-526-FOOT (3668) Mon-Fri 9AM - 5 PM EST

Image of Box and Label

BoxRiteAidAntiFungalPen.jpg  LabelRiteAidAntiFungalPen.jpg

INGREDIENTS AND APPEARANCE

RITE AID  MAXIMUM STRENGTH FOOT CARE ANTI-FUNGAL PEN
undecylenic acid liquid

Product 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)