OLIVE LEAF ACNE REMEDY- topical skin relief liquid

Olive Leaf Acne Remedy by

Drug Labeling and Warnings

Olive Leaf Acne Remedy by is a Homeopathic medication manufactured, distributed, or labeled by Vitality Works, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Olive Leaf Acne Remedy

Antimonium crudum 12X

Calcarea sulfurica 12X

Juglans regia 6X

Sulphur iodatum 30X

Olive Leaf Acne Remedy

USP Purified Water, Xylitol powder, Sodium Chloride, Olive Leaf Extract (Olea europa) 4X, Grapefruit Seed Extract, Sodium Hydroxide (for pH balance)

Olive Leaf Acne Remedy

-Do not apply in or around eyes. This product will sting your eyes. If product should get into your eyes, rinse with warm water.

-As with any drug. If you are pregnanat or nursing a baby, seek the advice of a health care professional before using this product.

-In case of accidental overdose by ingestion, seek profesional assistance or contact a poison control center immediately. All the ingredients are edible. However this product is not designed for internal use.

Olive Leaf Acne Remedy

Keep this and all drugs out of the reach of children. For children under 3 years of age, consult a health care professional.

Olive Leaf Acne Remedy

For the temporary relief of symptoms of acne, pimples, and cold sores.

For the temporary relief of eczema, burning and itching, and skin pustular eruptions.

Olive Leaf Acne Remedy

- First, thoroughly wash hands and the affected areas of the skin with warm soapy water, and rinse. Dry thoroughly.
- Apply a drop to fingertip and gently apply on affected skin.
- Repeat 2-3 times per day.
- For best results, continue using for a least one week after syptoms disappear.
- Reapply if symptoms return.

Olive Leaf Acne Remedy

Antimonium crudum - Relieves pimples; pustular eruptions with burning and itching; eczema

Calcarea sulfurica - Relieves pimples and pustules on the face and under hair

Juglans regia - Relives acne; itching; pimples on face, neck, shoulder and back

Sulphur iodatum - Relieves acne, itching; cold sores on lips; pustules on uppler lip

Olive Leaf Acne Remedy

INGREDIENTS AND APPEARANCE

OLIVE LEAF ACNE REMEDY 
topical skin relief liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64616-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U)	ANTIMONY TRISULFIDE	12 [hp_X]  in 1 mL
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM SULFATE ANHYDROUS	12 [hp_X]  in 1 mL
JUGLANS REGIA FLOWERING TOP (UNII: 3BA2N709NG) (JUGLANS REGIA FLOWERING TOP - UNII:3BA2N709NG)	JUGLANS REGIA FLOWERING TOP	6 [hp_X]  in 1 mL
SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0)	SULFUR IODIDE	30 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64616-069-02	1 in 1 CARTON	04/20/2011
1	NDC: 64616-069-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/20/2011

Labeler - Vitality Works, Inc (137752817)

Registrant - Vitality Works, Inc (137752817)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works, Inc		137752817	manufacture(64616-069)