TINEACIDE PHYSICIAN FORMULA - undecylenic acid cream 
TINEACIDE - undecylenic acid cream 
Blaine Labs Inc.

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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Active Ingredients

Undecylenic Acid

Inactive Ingredients

Aloe Vera, Cetyl Alcohol, Clotrimazole, Coco-Caprylate Caprate, Disodium EDTA, Glyceryl Stearate, Hydroxyethylcellulose, Lavender Oil, Methylparaben, PEG-100, Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water

Uses

Cures Athlete's Foot (tinea pedis) jock itch (tinea cruris) and ringworm (tinea corporis).

Uses

For effective relief of itching, cracking, burning and discomfort which can accompany these conditions.

Ask Your Physician

Do not use on children under 2 years of age unless directed by a physician

When Using This Product

Wash the affected area with soap and water and dry thoroughly.  Apply sparingly over affected area twice daily (morning and night) or as directed by a physician.  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.

Warnings

For external use only.  Avoid contact with eyes.  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 this and all drugs out of the reach of children.  In case of accidental ingestion seek professional assistance or contact a poison control center immediately.

Tineacide Label

Tineacide Antifungal Cream  Physician Formula
Dispensed by a physician only.
1.25 Ounce Label

1.25 Ounce Label - Physician Formula



TINEACIDE PHYSICIAN FORMULA 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65373-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CLOTRIMAZOLE (UNII: G07GZ97H65)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TEA TREE OIL (UNII: VIF565UC2G)  
TROLAMINE (UNII: 9O3K93S3TK)  
UREA (UNII: 8W8T17847W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65373-100-0135.4 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/1995
TINEACIDE 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65373-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CLOTRIMAZOLE (UNII: G07GZ97H65)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TEA TREE OIL (UNII: VIF565UC2G)  
TROLAMINE (UNII: 9O3K93S3TK)  
UREA (UNII: 8W8T17847W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65373-500-0135.4 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/1995
Labeler - Blaine Labs Inc. (017314571)
Registrant - Blaine Labs Inc. (017314571)
Establishment
NameAddressID/FEIBusiness Operations
Blaine Labs Inc.017314571manufacture

Revised: 1/2011
Document Id: e96c0c50-9c4d-4dc3-9eb8-481cabfc42fa
Set id: 3a7caf9f-2552-41be-a7d4-ac3a18b5a0d5
Version: 1
Effective Time: 20110121
 
Blaine Labs Inc.