Label: RESTORE- serrapeptase and huperzine a gel
RESTORE- serrapeptase and huperzine a liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 72186-021-21, 72186-022-22 - Packager: Key Origins, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 26, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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- Ingredients
- Descriptions
- SPL UNCLASSIFIED SECTION
- WARNINGS
- SPL UNCLASSIFIED SECTION
- Directions
- SPL UNCLASSIFIED SECTION
- Ingredients
- SPL UNCLASSIFIED SECTION
- WARNINGS
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- Descriptions
- Directions
- PRINCIPAL DISPLAY PANEL - 1 oz Jar Label
- PRINCIPAL DISPLAY PANEL - 2 oz Bottle Label
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INGREDIENTS AND APPEARANCE
RESTORE
serrapeptase and huperzine a gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72186-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Serrapeptase (UNII: NL053ABE4J) (Serrapeptase - UNII:NL053ABE4J) Serrapeptase 0.0492 mg in 1 mL Huperzine A (UNII: 0111871I23) (Huperzine A - UNII:0111871I23) Huperzine A 0.0317 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) Propanediol (UNII: 5965N8W85T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72186-021-21 30 mL in 1 JAR; Type 0: Not a Combination Product 12/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 12/02/2019 RESTORE
serrapeptase and huperzine a liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72186-022 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Serrapeptase (UNII: NL053ABE4J) (Serrapeptase - UNII:NL053ABE4J) Serrapeptase 0.0492 mg in 1 mL Huperzine A (UNII: 0111871I23) (Huperzine A - UNII:0111871I23) Huperzine A 0.0317 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Alcohol (UNII: 3K9958V90M) PROPANEDIOL (UNII: 5965N8W85T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72186-022-22 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 12/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 12/02/2019 Labeler - Key Origins, Inc. (072533626) Establishment Name Address ID/FEI Business Operations Key Origins, Inc. 072533626 MANUFACTURE(72186-021, 72186-022) , PACK(72186-021, 72186-022)