Rosacea Free
FDA Label NDC 52810-602

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 Rosacea Free (NDC 52810-602). 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.

Otc - Active Ingredient

ACTIVE INGREDIENTS

PINUS SILVESTRIS (1X) HPUS (PINE RESIN)

SAMBUCUS NIGRA (2X) HPUS (ELDERBERRY)

ORG. CALENDULA OFFICINALIS (2X) HPUS (MARIGOLD)

ABIES BALSAMEA (2X) HPUS (BALSAM FIR)

ECHINACEA ANGUSTIFOLIA (6X) HPUS

Otc - Purpose

PROPERTIES

SKIN PROTECTANT

ANTI-INFLAMMATORY

SKIN PROTECTANT

SKIN PROTECTANT

MULTI-PURPOSE SKIN HEALING REMEDY

Indications & Usage

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH EXTREMELY DRY, DAMAGED, INFLAMED OR AGING SKIN.

Dosage & Administration

DIRECTIONS: APPLY TO CLEAN, DRY AFFECTED AREA MORNING AND NIGHT, AS NEEDED UNTIL CONDITION CLEARS. THEN APPLY NIGHTLY TO MAINTAIN HEALTHY SKIN.

Inactive Ingredient

OTHER INGREDIENTS: ORGANIC BEESWAX, ORGANIC OLIVE OIL, ORGANIC ARGAN OIL, ORGANIC SEA BUCKTHORN OIL

Warnings

WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER. (* = CERTIFIED ORGANIC INGREDIENTS)

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Otc - Questions

CUSTOMER SERVICE 310-526-6108

Other Safety Information

STORE IN A COOL DRY PLACE OR REFRIGERATE

* Please review the disclaimer below.