NDC | 63347-503-01 |
Set ID | b328a052-7456-4e34-b9ed-4c4219ff0451 |
Category | HUMAN OTC DRUG LABEL |
Packager | Blaine Labs Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
-
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
-
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 CREAMMONEY BACK
100%
GUARANTEEDr. Blaine's®
TINEACIDE+®
ANTIFUNGAL CREAMMAXIMUM
STRENGTH
FUNGUS TREATMENT1.25 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.comQuestions 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 CREAMADVANCED
FORMULATION
NOW CONTAINING CARVACROLWILL 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.com05001-01 REV 20190326
res
-
INGREDIENTS AND APPEARANCE
TINEACIDE ANTIFUNGAL MAXIMUM STRENGTH
miconazole nitrate creamProduct 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)