Otc - Active Ingredient
ACTIVE INGREDIENTS
CALENDULA OFFICINALIS (1X) HPUS (MARIGOLD)
ECHINACEA ANGUSTIFOLIA (1X) HPUS (ECHINACEA)
SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)
All Natural Wound And Burn
FDA Label NDC 52810-219
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 All Natural Wound And Burn (NDC 52810-219). 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 otc - active ingredient, otc - purpose, indications & usage, dosage & administration, inactive ingredient, warnings, otc - keep out of reach of children, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PURPOSE
SWELLING, ITCHY SKIN, RED SPOTS WITH BURNING SENSATION
WOUND HEALING, SUPERFICIAL BURNS, SUNBURN AND SCALDS
DRY AND ITCHY SKIN, SKIN IRRITATION FROM INSECT BITES
Indications & Usage
USES: TEMPORARITY RELIEVES SYMPTOMS ASSOCIATED WITH MINOR SKIN WOUNDS,
SUNBURN, SUPERFICIAL BURNS, SWELLING AND ITCHING. ALSO MAY BE USED TO CLEAN
WOUNDS. PRODUCT USES ARE BASED ON HOMEOPATHIC MATERIA MEDICA. THESE "USES"
HAVE NOT BEEN EVALUATED BY THE FDA.
Dosage & Administration
DIRECTIONS: TEST FOR ALLERGY BY APPLYING A SMALL AMOUNT ON SKIN BEFORE USE.
APPLY TOPICALLY TO AFFECTED AREA 2-6 TIMES A DAY, OR AS DIRECTED BY YOUR PHYSICIAN.
Inactive Ingredient
INACTIVE INGREDIENTS: ORGANIC ALOE, ORGANIC OLIVE OIL (EXTRA VIRGIN), WILD HARVESTED PINE EXTRACT
Warnings
WARNING: 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
PRIOR REACTION TO THIS SALVE, STOP USE AND ASK A DOCTOR IF SYMPTOMS
PERSIST OR WORSEN. AVOID CONTACT WITH EYES.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Otc - Questions
QUESTIONS OR COMMENTS: CALL 818-851-9014 BETWEEN8:AM - 5:PM PST
* Please review the disclaimer below.
