TINEACIDE- tolnaftate liquid

TINEACIDE by

Drug Labeling and Warnings

TINEACIDE by is a Otc medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Drug facts

Active Ingredient

TOLNAFTATE 1%

Purpose

Purpose

Antifungal

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.

Indications

Indications

• Cures most athlete's foot (tinea pedis).
• Cures most jock itch (tinea cruris) and ring worm (tinea corporis).
• Relieves itching, cracking, burning, and scaling which accompany these conditions.
• Prevents most athlete's foot (tinea pedis) with daily use.
  

Warnings

Warnings

• Do not use
• on children under 2 years of age unless directed by a physician
• in or near mouth or eyes
• for vaginal yeast infections
• For external use only
  

When Using This Product

When using this product avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water.

Stop Use And Consult A Physician

Stop use and ask a physician if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

Directions

Directions

• Wash the affected ares with soap and water and dry thoroughly. Apply a thin layer over affected area twice daily (morning and night) or as directed by a physician.
• 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.
• For athlete's foot and ringworm, use daily for 4 weeks.
• For jock itch, use daily for 2 weeks. If condition persists longer, consult a physician.
• wash hands after each use.
  

Other Information

Other Information

• Store at room temperature.
  

Questions?

Questions?

Call (800)307-8818, Monday through Friday, 8:00 AM to 5:00 PM (Pacific Time).

Inactive Ingredients

Inactive Ingredients

Paraffnum Liquidum, Carthamus Tinctorius (Safflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Oreganum Vulgaris (Oregano) Leaf Oil, Tocopheryl acetate, BHT, BHA, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylpapaben.

Package Label Tineacide Solution Physician Formula

Blaine Labs

TINEACIDE SOLUTION PHYSICIAN FORMULA

Antifungal Treatment

Dispensed Only by Physicians

NDC: 63347-511-03

15ml (1/2 oz.)

Proudly Made in the USA

Please Recycle! This package is made from recyclable materials.

Exp. / Lot #

Patent Pending

Blaine Labs

Manufactured by

Blaine Labs, Inc

11037 Lockport Place

Sante Fe Springs, CA 90670

27000-P-BX Rev. 20120921

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INGREDIENTS AND APPEARANCE

TINEACIDE  
tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-511
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	140 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
SAFFLOWER OIL (UNII: 65UEH262IS)
JOJOBA OIL (UNII: 724GKU717M)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
BUTYLPARABEN (UNII: 3QPI1U3FV8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-511-03	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/19/2012

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-511)