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- NDC Code(s): 84048-001-01
- Packager: Shenzhen Peruidaishi Technology Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 25, 2024
If you are a consumer or patient please visit this version.
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- Active Ingredient
Miconazole nitrate 2%
- Purpose
- Use
This product facilitates the recovery of nailsinfluenced by nail fungus and aids in avertingrecurrent athlete's foor through daily usage.lteffectively targets diverse conditions likeomychomycosis, atrophy, uneven surfacesmstratification, nail thickening, yellowing, nailremoval, turbidity, discoloration, and other nailirregulartes.Beyondresoling these concerns,our product goes further by nurturing nails,encouraging their natural repair process, andgently reinstating theirinnate smoothness andluster.
- Warnings
* Do not use the product on children under 10 years ofage unless directed by a doctor.
*Forexternal use only. if swallowed, seek immediatemedical assistance.
*Safeguard the product from children to avert anychance of accidentalingestion..lmmediate discontinuation is advised in case of
discomfort or irritation.* Refrain from applying the product on injured orswollen skin areas.
*Forindividuals with sensitive skin, a patch test on thewrist's interior isrecommended before use,ensuring anirritation-free experience.
*Keep the product away from the eyes to preventcontact.
- Do not use
Do not use the product on children under 10 years ofage unless directed by a doctor.
lmmediate discontinuation is advised in case of discomfort or irritation. - When Using
It is normal for nails to temporarilyexhibit a yellow hue during treatmentdue to the liquid's color.This willgradually recede as your toenailsregain their health.
- Stop Use
immediate discontinuation is advised in case of discomfort or irritation.
- Keep Oot Of Reach Of Children
Keep Out Of Reach Of Chlidren
- Directions
Begin by soaking your feetvom warm water for 5minutes. Afterward, ensure thorough drying of yourto es.
Emnploy a fingemail clipper (not included) and a nailfile to meticulously eliminate as much damaged nailarea as possible.This pivotalstep maximizes theabsorption potential of our nail fungus treatment liquidApply an appropriate quantity of the liquid to theareas requiring repair.Repeat this proces 2-3 times daily until a healthy nailstarts its gradual regeneration, For optimal results,maintain usage for a continuous 6-week period. - Other information
Store the productin a cool, shaded place, shieldedfrom direct sunight.Maintain atroom temperaturebetween 15-300c(59-86*). To prevent any accidents,keep it out of children's reach.
- Inactive ingredients
Water
Sorbitol
Alcohol
Propylene Glycol
Angelica Dahurica Root
Laurocapram
Caramel
Dimethylol Urea
FD&C Yellow No. 6 - PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
RECUREN PLUS FUNGAL NAIL RENEWAL
fungal nail renewal liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84048-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2g in100mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LAUROCAPRAM (UNII: 1F3X9DRV9X) CARAMEL (UNII: T9D99G2B1R) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) OXYMETHUREA (UNII: N68H97CAWG) SORBITOL (UNII: 506T60A25R) ALCOHOL (UNII: 3K9958V90M) ANGELICA DAHURICA ROOT (UNII: 1V63N2S972) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84048-001-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 01/24/2024 Labeler -Shenzhen Peruidaishi Technology Co., Ltd.(706728459)
Establishment Name Address ID/FEI Business Operations Shenzhen Peruidaishi Technology Co., Ltd. 706728459 manufacture(84048-001) , label(84048-001)
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RECUREN PLUS FUNGAL NAIL RENEWAL- fungal nail renewal liquid
Number of versions: 1
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Jan 26, 2024 | 1 (current) | download |
RxNorm
RECUREN PLUS FUNGAL NAIL RENEWAL- fungal nail renewal liquid
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 998525 | miconazole nitrate 2 % Topical Solution | PSN |
| 2 | 998525 | miconazole nitrate 20 MG/ML Topical Solution | SCD |
| 3 | 998525 | miconazole nitrate 2 % Topical Solution | SY |
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RECUREN PLUS FUNGAL NAIL RENEWAL- fungal nail renewal liquid
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NDC Codes
RECUREN PLUS FUNGAL NAIL RENEWAL- fungal nail renewal liquid
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 84048-001-01 |
