Label: TINEACIDE PHYSICIAN FORMULA- undecylenic acid cream
TINEACIDE- undecylenic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 65373-100-01, 65373-500-01 - Packager: Blaine Labs Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 21, 2011
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- Active Ingredients
- Inactive Ingredients
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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.
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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
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INGREDIENTS AND APPEARANCE
TINEACIDE PHYSICIAN FORMULA
undecylenic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65373-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 13 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:65373-100-01 35.4 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/01/1995 TINEACIDE
undecylenic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65373-500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 10 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:65373-500-01 35.4 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/01/1995 Labeler - Blaine Labs Inc. (017314571) Registrant - Blaine Labs Inc. (017314571) Establishment Name Address ID/FEI Business Operations Blaine Labs Inc. 017314571 manufacture