Baby Skin
FDA Label NDC 52810-201

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 Baby Skin (NDC 52810-201). 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, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

ACTIVE INGREDIENTS

PINUS SILVESTRIS (2X) HPUS (PINE RESIN)

ORG. SAMBUCUS NIGRA (3X) HPUS (ELDERBERRY)

ORG. CALENDULA OFFICINALIS (6X) HPUS (MARIGOLD)

ORG. ECHINACEA ANGUSTIFOLIA (6X) HPUS (ECHINACEA)

Otc - Purpose

PROPERTIES

SKIN PROTECTANT

ANTI-INFLAMMATORY

PROMOTES SKIN HEALING

REMEDY FOR WOUNDS

Indications & Usage

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH SKIN IRRITATIONS, ECZEMA, RASH, DRY SKIN, CUTS, BURNS, OPEN WOUNDS, AND MUCH MORE.

Dosage & Administration

DIRECTIONS: APPLY TO AFFECTED AREA 3-4 TIMES PER DAY AS NEEDED. COVER WITH A BANDAID IF NECESSARY.

Inactive Ingredient

OTHER INGREDIENTS: ORGANIC EXTRA VIRGIN OLIVE OIL, HIGH OLEIC SAFFLOWER OIL, ORGANIC BEESWAX, CANADIAN BALSAM FIR.

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.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Other Safety Information

STORE IN A COOL DRY PLACE OR REFRIGERATE

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