Label: ANTI FUNGAL- coltrimazole liquid
- NDC Code(s): 71582-001-10
- Packager: Guangzhou Ertiantang Pharmaceutical Co.,Ltd
- 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.
Updated August 23, 2017
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- Active Ingredients
Coltrimazole 1% AntifungalClose
• For the cure of athlete's foot (tinea pedis), jock itch (tinea cruris) and ring worm (tinea corporis).Close
• For relief of itching, scaling, burning and discomfort that accompany these conditions.
For External Use Only.Close
- Do Not Use
On children under 2 years of age unless directed by a doctor.Close
- Stop Use and Ask a Doctor if
• Irritation occurs or if there is no improvement within 4 weeks (for athlete’s foot).Close
• If irritation occurs or if there is no improvement within 4 weeks (for jock itch).
• If condition persists longer, consult a doctor.
- When Use This Product
• Avoid contact with the eyes.Close
• This product is not effective on the scalp or nails.
- Keep Out of Reach of Children
If swallowed, get medical help or contact a Poison Control Center right away.Close
Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. 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.Close
Store in cool, dry place away from direct sunlight.Close
- Inactive Ingredients
GLACIAL ACETIC ACID, GARLIC OIL, OSTHOL, SOPHORA FLAVESCENS ROOT, PSEUDOLARIX AMABILIS BARK，PHRYMA LEPTOSTACHYA WHOLE, PHELLODENDRON CHINENSE WHOLEClose
- SPL UNCLASSIFIED SECTION
Bluebird Health Company
3856 Walnut Grove Avenue
Rosemead, CA 91770-1655
Made in ChinaClose
- Drug Facts
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71582-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength ACETIC ACID (UNII: Q40Q9N063P) GARLIC OIL (UNII: 4WG8U28833) OSTHOL (UNII: XH1TI1759C) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE) PHRYMA LEPTOSTACHYA WHOLE (UNII: 6G287VJM69) PHELLODENDRON CHINENSE WHOLE (UNII: QKA3ZK8IIE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71582-001-10 1 in 1 CARTON 09/22/2017 1 300 mL in 1 PACKAGE; 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 09/22/2017 Labeler - Guangzhou Ertiantang Pharmaceutical Co.,Ltd (546747036) Registrant - Guangzhou Ertiantang Pharmaceutical Co.,Ltd (546747036) Establishment Name Address ID/FEI Business Operations Guangzhou Ertiantang Pharmaceutical Co.,Ltd 546747036 manufacture(71582-001)