Rite Aid Corporation Jock Itch Powder Spray Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

JOCK ITCH- tolnaftate spray 
Rite Aid Corporation

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.

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Rite Aid Corporation Jock Itch Powder Spray Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of most jock itch (tinea cruris)
• effectively soothes and relieves symptoms of jock itch
• itching
• chafing
• burning

Warnings

For external use only

Flammable: Do not use near flame or spark or while smoking.

Do not use

on children under 2 years of age unless directed by a doctor

When using this product

• avoid contact with the eyes
• contents under pressure. Do not puncture or incinerate or store at temperatures above 120°F (49°C).
• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 2 weeks

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the affected area and dry thoroughly
• shake can well before use
• hold can about 6 inches from the area to be treated
• spray a thin layer over the affected area twice daily (morning and night)
• supervise children in the use of this product
• use daily for 2 weeks. If condition lasts longer, ask a doctor.
• this product is not effective on the scalp or nails
• in case of clogging, clean nozzle with a pin

Inactive ingredients

alcohol SD 40-B, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propane, propylene carbonate, sorbitan monooleate, stearalkonium hectorite, talc

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the Active Ingredient of Tinactin®

Maximum Strength

Jock Itch

POWDER SPRAY

Tolnaftate 1%

Antifungal

Cures Most Jock Itch

Soothes and Relieves Itching, Burning and Chafing

Jock Itch Powder Spray Label

Jock Itch Powder Spray Label

JOCK ITCH 
tolnaftate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0695
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ISOBUTANE (UNII: BXR49TP611)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPANE (UNII: T75W9911L6)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	WHITE (off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0695-1	130 g in 1 CAN; Type 0: Not a Combination Product	10/12/2004	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/12/2004	05/01/2019

Labeler - Rite Aid Corporation (014578892)

Revised: 5/2019

Document Id: 56f64fb9-8dc8-49f6-a89e-7344d66b45f2

34390-5

Set id: 065a5fa2-e9ce-4f5e-aa6d-62eaef9156f9

Version: 2

Effective Time: 20190516