Label: ALOE- aloe vera leaf pellet
- NDC Code(s): 60512-6475-1
- Packager: HOMEOLAB USA INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT HPUS
ALOE SOCOTRINA 6X
For self-limiting condition listed above or as directed by a health professional.Close
Adults: Allow 3 or 4 pellets to dissolve in the mouth 3 times a day until symptoms are relieved or as directed by a health professional.Close
- OTHER INFORMATION
Store at room temperature.Close
- INACTIVE INGREDIENTS
The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.
These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.
Mfd for: HOMEOLAB USA INC., 3025 De L`Assomption, Montreal, QC, H1N 2H2, CANADA
Product of CanadaClose
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60512-6475 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF 6 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60512-6475-1 80 in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/14/2013 Labeler - HOMEOLAB USA INC. (202032533) Registrant - HOMEOLAB USA INC. (202032533) Establishment Name Address ID/FEI Business Operations HOMEOLAB USA INC. 202032533 manufacture(60512-6475)