Rash Relief
FDA Label NDC 52810-218

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puremedy for the product Rash Relief (NDC 52810-218). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, directions, inactive ingredients, warnings, otc - keep out of reach of children, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

EACH DOSE CONTAINS EQUAL PARTS OF

ARNICA MONTANA 1X HPUS (ARNIC)

cALENDULA OFFICINALIS 1X HPUS (MARIGOLD)

SAMBUCUS NIGRA 1 X (ELDERBERRY)

Purpose

ITCHY AND BURNING SKIN

WOUND HEALING

SWELLING, RED BURING SPOTS ON CHEEKS

Uses

TEMPORARILY RELIEVES SYMPTOMS COMMONLY ASSOCUATED WITH RASHES. PRODUCT USES ARE BASED ON HOMEOPATHIS MATERIA MEDICA. THESE 'USES' HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT HAS NOT BEEN CLINICALLY TESTED BY PUREMEDY INC.

Directions

TEST FOR ALLERGY BY RUBBING a small amount on skin before use. apply topically to affected area 2-3 times a day, or as directed by your physician.

Inactive Ingredients

CASTOR OIL, HYDROGENATED CASTOR OIL WAX, EXTRA VIRGIN OLIVE OIL

Warnings

FOR EXTERNAL USE ONLY. DO NOT USE IF YOU HAVE AN ALLERGY OR HYPERSENSITIVITY TO THE COMPONENTS OF THE FORMULA OR IF YOU HAVE HAD A PRIOR REACTION TO THIS SALVE. STOP USE AND ASK A DOCTOR IF SYMPTOMS PERSISTS OR WORSEN. AVOID  CONTACT WITH EYES.

Otc - Keep Out Of Reach Of Children

KEEP ALL DRUGS OUT OF REACH OF CHILDREN.

Questions Or Comments?

CALL 818-851-9014 BETWEEN 8:AM AND 5:PM PST

Package Label.Principal Display Panel

Rashrelief_1oz_2015 (Rashrelief 1oz 2015)

Rashrelief_1oz_2015 (Rashrelief 1oz 2015)

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