Label: HC MAX HONGO CURA MS- undecylenic acid spray
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- NDC Code(s): 0295-1032-05, 0295-1032-11, 0295-1032-12, 0295-1032-16
- Packager: Denison Pharmaceuticals, LLC.
- 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 February 6, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses
- Warnings
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Clean affected area and dry thoroughly.
- Spray HC Max™ anti-fungal liquid onto 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. If condition persists longer, consult a doctor
- This product is not effective on the scalp or nails
- STORAGE AND HANDLING
- Inactive ingredient
- HC MAX HONGO CURA MS (UNDECYLENIC ACID) SPRAY
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INGREDIENTS AND APPEARANCE
HC MAX HONGO CURA MS
undecylenic acid sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0295-1032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 25 mg in 100 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0295-1032-12 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2017 2 NDC:0295-1032-05 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2017 02/06/2019 3 NDC:0295-1032-11 1.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 01/01/2017 02/06/2019 4 NDC:0295-1032-16 3 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 01/01/2017 02/06/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/01/2017 Labeler - Denison Pharmaceuticals, LLC. (001207208) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC. 001207208 manufacture(0295-1032)
