BABY DIAPER RASH- calendula officinalis flower and sambucus nigra flower salve
PUREMEDY

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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ACTIVE INGREDIENTS

ORG. CALENDULA OFFICINALIS (1X) HPUS) (MARIGOLD)

ORG. SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)

PURPOSE

SOOTHES RASH, IRRITATION

REMEDY FOR SWELLING

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH DIAPER RASH AND MINOR SKIN IRRITATIONS. SOOTHES SKINS AND PROTECTS AGAINST MOISTURE TP PROMOTE HEALING.

DIRECTIONS: APPLY TO CLEAN SKIN AFTER EACH DIAPER CHANGE OR AS DIRECTED BY YOUR PHYSICIAN. MAY ALSO BE USED AS A DAILY SKIN PROTECTANT.

INACTIVE INGREDIENTS: ORG. OLIVE OIL, ORG. BEESWAX, MILD PROPRIETARY BLEND OF PINE AND FIR EXTRACTS, ORG. COCOA BUTTER, ORG. MILK THISTLE, ORG. ST. JOHN'S WORT, ORG. ALOE VERA GEL, ORG. NON-GMO VITAMIN E

WARNINGS: DO NOT USE IF ALLERGIC TO OR SENSITIVE TO ANY INGREDIENT IN THIS SALVE. TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN BEFORE USE. IF CONDITION PERSISTS OR WORSENS AFTER 3 DAYS SEE A DOCTOR. AVOID DIRECT CONTACT WITH EYES. USE ONLY AS DIRECTED. KEEP ALL DRUGS OUT OF USE OF CHILDREN. SAFE TO USE FOR ALL AGES.

KEEP ALL DRUGS OUT OF REACH OF CHILDREN.

STORE IN A COOL DRY PLACE OR REFRIGERATE.

CUSTOMER SERVICE 818-851-9014

1oz_BabyDiaperRash

BABY DIAPER RASH
calendula officinalis flower, sambucus nigra flower salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52810-216
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X] in 100 mL
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T)	SAMBUCUS NIGRA FLOWER	1 [hp_X] in 100 mL

Ingredient Name	Strength
Inactive Ingredients
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANADA BALSAM (UNII: K304VI98I3)
COCOA BUTTER (UNII: 512OYT1CRR)
SILYBUM MARIANUM SEED (UNII: U946SH95EE)
ST. JOHN'S WORT (UNII: UFH8805FKA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52810-216-11	30 mL in 1 JAR; Type 0: Not a Combination Product

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

Labeler - PUREMEDY (003552251)

Name	Address	ID/FEI	Business Operations
Establishment
COASTAL CONTRACT PACKAGING, INC.		137341611	manufacture(52810-216)

Revised: 6/2015

Document Id: 2038da0c-23a8-4f46-a440-da82f647f3dc

Set id: 1b81ef0c-2ab6-4f1b-a062-06a776491bb2

Version: 4

Effective Time: 20150604

PUREMEDY