The following Structured Product Label (SPL) was submitted to the FDA by Puremedy for the product Extra Drawing Acne Relief (NDC 52810-103). 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, 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.
ORGANIC BERBERIS AQUIFOLIUM (1X) HPUS (MOUNTAIN GRAPE)
ORGANIC CALENDULA OFFICINALIS (1X) HPUS (MARIGOLD)
ORGANIC ECHINACEA ANGUSTIFOLIA (1X) HPUS (ECHINACEA)
ORGANIC SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)
ORGANIC THUJA OCCIDENTALIS (1X) HPUS (ARBOR VITAE)
ACNE
WOUND HEALING
SMALL RED PIMPLES ON NECK AND FACE
SWELLING, RED SPOTS BURNING
ACNE
TEMPORARILY RELIEVES SYMPTOMS SUCH AS RED SPOTS, PUSTULES, BURNING AND OTHER IRRITATIONS ASSOCIATED WITH ACNE. PRODUCT USES ARE BASED ON HOMEOPATHIC MATERIA MEDICA. THESE 'USES' HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT HAS NOT YET BEEN CLINICALLY TESTED BY PUREMEDY INC.
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 OR HEALTH CARE PRACTITIONER.
BEESWAX*, BLOODROOT, CANADIAN FIR BALSAM**, LAVENDER OIL*, OLIVE OIL*, PINE EXTRACT**
*ORGANIC **WILD HARVESTED
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 PERSIST OR WORSEN. AVOID CONTACT WITH EYES.
IF SWALLOWED CONTACT A HEALTH CARE PROVIDER OR POISON CONTROL CENTER RIGHT AWAY.
CALL 818-851-9014 BETWEEN 8:AM AND 5:PM PST
*SEE BOX FOR FULL INFORMATION.
* Please review the disclaimer below.
