BABY SKIN (pine needle oil- pinus sylvestris sambucus nigra flower calendula officinalis flower echinacea angustifolia salve

BABY SKIN by

Drug Labeling and Warnings

BABY SKIN by is a Homeopathic medication manufactured, distributed, or labeled by PUREMEDY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

OTHER SAFETY INFORMATION

STORE IN A COOL DRY PLACE OR REFRIGERATE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY SKIN 
pine needle oil (pinus sylvestris) sambucus nigra flower calendula officinalis flower echinacea angustifolia salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52810-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	6 [hp_X]  in 100 mL
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T)	SAMBUCUS NIGRA FLOWER	3 [hp_X]  in 100 mL
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	3 [hp_X]  in 100 mL
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) (PINE NEEDLE OIL (PINUS SYLVESTRIS) - UNII:5EXL5H740Y)	PINE NEEDLE OIL (PINUS SYLVESTRIS)	2 [hp_X]  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
SAFFLOWER OIL (UNII: 65UEH262IS)
YELLOW WAX (UNII: 2ZA36H0S2V)
ABIES BALSAMEA LEAF OIL (UNII: 2FGT9T2SQC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52810-201-11	30 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/18/2012

Labeler - PUREMEDY (003552251)

Establishment
Name	Address	ID/FEI	Business Operations
COASTAL CONTRACT PACKAGING, INC.		137341611	manufacture(52810-201)