BABY ACNE- calendula officinalis flower, sambucus nigra flower, thuja occidentalis salve

BABY ACNE by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

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

ORG. SAMBUCUS NIGRA (1X) HPUS (ELDER BARK AND FLOWER)

ORG. THUJA OCCIDENTALIS (1X) HPUS (ARBOR VITAE)

PURPOSE

PURPOSE

SKIN HEALING AGENT

REMEDY FOR SWELLING

REMEDY FOR ACNE

INDICATIONS & USAGE

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH BABY ACNE.

DOSAGE & ADMINISTRATION

DIRECTIONS: APPLY TOPICALLY AS NEEDED OR AS DIRECTED BY YOUR PHYSICIAN.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: ORG. OLIVE OIL, ORG. BEESWAX, ORG. COCOA BUTTER, MILD PROPRIETARY BLEND OF PINE AND FIR EXTRACTS

WARNINGS

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 OUT OF REACH OF CHILDREN

KEEP ALL DRUGS OUT OF REACH OF CHILDREN.

STORAGE AND HANDLING

STORE IN A COOL DRY PLACE OR REFRIGERATE.

QUESTIONS

CUSTOMER SERVICE 818-851-9014

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY ACNE 
calendula officinalis flower, sambucus nigra flower, thuja occidentalis salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52810-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786)	THUJA OCCIDENTALIS LEAF	1 [hp_X]  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCOA BUTTER (UNII: 512OYT1CRR)
CANADA BALSAM (UNII: K304VI98I3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52810-214-11	30 mL in 1 JAR; Type 0: Not a Combination Product	10/18/2012

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
PUREMEDY		003552251	manufacture(52810-214)