Label: TOLNAFTATE- tolnaftate aerosol, spray
- NDC Code(s): 11673-448-05
- Packager: Target Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient
- cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
- if used daily, can prevent recurrence of athlete's foot
- relieves sypmtoms of athlete's foot, including itching, burning and cracking
For external use only.
Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF.
When using this product
- do not get into eyes or mouth
- use only as directed
Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.
Stop use and ask a doctor if
- irritation occurs
- no improvement within four weeks (for athlete's foot) or two weeks (for jock itch)
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under two years of age unless directed by a doctor.
- wash affected area and dry thoroughly
- shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product
- 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
- use daily for 4 weeks; if conditions persist, consult a doctor
- to prevent athlete's foot, appl morning and/or night
- this product is not effective on the scalp or nails
- Other information
store between 20º and 30ºC (68ºF and 86º)Close
- Inactive ingredients
BHT, isobutane (propellant), PPG-12-buteth-16, SD alcohol 40-B(36%w/w)Close
- Principal Display Panel
antifungal liquid spray
Compare to Tinactin® Liquid Spray
cures and prevents most athlete's foot
cures most jock itch and ringworm
helps relieve burning and itching
Net WT 5.3 OZ (150.2g)
- INGREDIENTS AND APPEARANCE
antifungal liquid spray aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-448 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1.5 g in 150.2 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ISOBUTANE (UNII: BXR49TP611) PPG-12-BUTETH-16 (UNII: 58CG7042J1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-448-05 150.2 g in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/31/2008 Labeler - Target Corporation (006961700) Establishment Name Address ID/FEI Business Operations Premier Brands of America Inc. 063849780 relabel(11673-448)