TINEACIDE ANTIFUNGAL MAXIMUM STRENGTH- miconazole nitrate cream

TINEACIDE ANTIFUNGAL by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient
Miconazole Nitrate 2%

PURPOSE

Purpose
Antifungal

INDICATIONS & USAGE

Uses
Cures most athlete’s foot (tinea pedis).
Cures most jock itch (tinea cruris) and ringworm (tinea corporis).
Relieves discomfort, irritation, cracking, scaly skin between the
   toes and itching, burning feet.

WARNINGS

Warnings
Do not use on children under 2 years of age unless directed by a
   physician.
For external use only.
Do not use for vaginal yeast infections.
Avoid contact with the eyes. If eye contact occurs, rinse thoroughly
  with water.

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),
discontinue use and consult a physician.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact

the Poison Control Center right away at 800.222.1222

DOSAGE & ADMINISTRATION

Directions
Wash the affected area with soap and water and dry thoroughly.
Apply a thin layer of the product 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 doctor.
This product is not effective on the scalp or nails.
Wash hands after each use.

OTHER SAFETY INFORMATION

Other Information
Do not use if seal on bottle is broken or is not visible.
Store between 2˚ and 30˚ C (36˚ and 86˚ F).

INACTIVE INGREDIENT

Inactive Ingredients
Water (aqua), Cetyl Alcohol, PEG 100 Stearate, Glyceryl Stearate, Stearic
Acid, Coco-Caprylate/Caprate, Polysorbate 60, Triethanolamine, Urea,
Hydroxyethylcellulose, Disodium EDTA, Methylparaben, Propylparaben,
Lavandula Angustifolia Lavender Oil, Tea Tree Oil, Clortrimazole, Aloe,
Barbadensis Leaf Juice, Origanum Vulgare Leaf Oil (content carvacrol),
Olea Europaea (Olive) Fruit Oil

Principal Display Package

Dr. Blaine's®
TINEACIDE+®
ANTIFUNGAL CREAM

MONEY BACK
100%
GUARANTEE

Dr. Blaine's®
TINEACIDE+®
ANTIFUNGAL CREAM

MAXIMUM
STRENGTH
FUNGUS TREATMENT

1.25 OZ (36.9mg)

6 16728 00004  0

Dr. Robert Blaine developed
Tineacide® Antifungal Cream in 1995
because he suffered the loss of his
foster father due to complications
from diabetes and fungal foot
infection. Dr. Blaine chose to
devote his career to podiatry and proper
foot care. 25 years later, Tineacide®
has become synonymous with
antifungal foot care products that
actually work to kill foot fungus.

To see Dr. Blaine’s full story, go to
TINEACIDE.com

Questions or Comments? Call 800.307.8818 Monday - Friday,
8:00 AM and 5 PM (PST)
All rights reserved. Made in the U.S.A.

Please recycle.

TINEACIDE+®
ANTIFUNGAL CREAM

ADVANCED
FORMULATION
NOW CONTAINING CARVACROL

WILL ELIMINATE YOUR FOOT
FUNGUS OR WE WILL REFUND YOUR
MONEY IF IT DOESN’T WORK
FOR YOU!

ELIMINATES ODORS

KILLS THE SKIN FUNGUS
   THAT CAUSES FUNGAL
   NAILS

TREATS MILD TO SEVERE
   INFECTIONS

MEDICAL GRADE
   ADVANCED FORMULA

100% MONEY-BACK
   GUARANTEE!

Manufactured by: Blaine Labs, Inc.
11307 Lockport Place
Santa Fe Springs, CA 90670
800.307.8818 | www.TINEACIDE.com

05001-01                        REV 20190326

res

INGREDIENTS AND APPEARANCE

TINEACIDE ANTIFUNGAL  MAXIMUM STRENGTH
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	0.7 g  in 35 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TROLAMINE (UNII: 9O3K93S3TK)
UREA (UNII: 8W8T17847W)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
CLOTRIMAZOLE (UNII: G07GZ97H65)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
OLIVE OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-503-01	1 in 1 BOX	03/01/2019
1		35 g in 1 BOTTLE; 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	03/01/2019

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-503)