Olive Leaf Acne Remedy

Manufacturer: Vitality Works, Inc
Effective date: 2025-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 02:36:15

Label at a glance#

ProductOlive Leaf Acne Remedy

Active ingredientANTIMONY TRISULFIDE, CALCIUM SULFATE ANHYDROUS, JUGLANS REGIA FLOWERING TOP, SULFUR IODIDE

Label structure8 sections

Label contents#

Full prescribing information#

Olive Leaf Acne Remedy

OTC - ACTIVE INGREDIENT SECTION

Antimonium crudum 12X

Calcarea sulfurica 12X

Juglans regia 6X

Sulphur iodatum 30X

Olive Leaf Acne Remedy

INACTIVE INGREDIENT SECTION

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

WARNINGS SECTION

-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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

- 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

OTC - PURPOSE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Olive Leaf Acne Remedy Carton

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0019277000675	GTIN-13: 0019277000675 EAN-13: 0019277000675 GTIN-12: 019277000675 UPC-A: 019277000675 GTIN storage (14 digits): 00019277000675	Olive Leaf Acne Remedy Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64616-069-01	Olive Leaf Acne Remedy	30 mL in 1 BOTTLE, PLASTIC	LIQUID	30		9
64616-069-02	Olive Leaf Acne Remedy	1 in 1 CARTON	LIQUID	1		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ANTIMONY TRISULFIDE	ACTIVE INGREDIENT	F79059A38U	2
CALCIUM SULFATE ANHYDROUS	ACTIVE INGREDIENT	E934B3V59H	2
JUGLANS REGIA FLOWERING TOP	ACTIVE INGREDIENT	3BA2N709NG	2
SULFUR IODIDE	ACTIVE INGREDIENT	L6L8KA2AA0	2
ANTIMONY TRISULFIDE	ACTIVE MOIETY	F79059A38U	2
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	2
JUGLANS REGIA FLOWERING TOP	ACTIVE MOIETY	3BA2N709NG	2
SULFUR IODIDE	ACTIVE MOIETY	L6L8KA2AA0	2
CITRUS PARADISI SEED	INACTIVE INGREDIENT	12F08874Y7	2
OLEA EUROPAEA LEAF	INACTIVE INGREDIENT	MJ95C3OH47	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Olive Leaf Acne Remedy
Topical Skin Relief
BENZALKONIUM CHLORIDE
WATER
OLEA EUROPAEA LEAF
SODIUM HYDROXIDE
ANTIMONY TRISULFIDE
CALCIUM SULFATE ANHYDROUS
CALCIUM CATION
JUGLANS REGIA FLOWERING TOP
SULFUR IODIDE
MAGNESIUM DISODIUM EDTA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64616-069	64616-069-01, 64616-069-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
WATER	059QF0KO0R	IACT
OLEA EUROPAEA LEAF	MJ95C3OH47	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
ANTIMONY TRISULFIDE	F79059A38U	ACTIB
CALCIUM SULFATE ANHYDROUS	E934B3V59H	ACTIB
JUGLANS REGIA FLOWERING TOP	3BA2N709NG	ACTIB
SULFUR IODIDE	L6L8KA2AA0	ACTIB
MAGNESIUM DISODIUM EDTA	NDT563S5VZ	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 84 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL		1500 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	GUM, CHEWING / BUCCAL		11915 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SPRAY / SUBLINGUAL		22 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	GUM, CHEWING / BUCCAL		11915 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii+dosage form 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii+dosage form 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii+dosage form 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / TOPICAL	0.86 %w/v		Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii+dosage form 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, ORALLY DISINTEGRATING / ORAL		360 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii+dosage form 45 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / TOPICAL	0.86 %w/v		Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / TOPICAL		210 mg	Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii+dosage form 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, ORALLY DISINTEGRATING / ORAL		360 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii+dosage form 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii+dosage form 45 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / TOPICAL		210 mg	Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olive Leaf Acne Remedy	TOPICAL SKIN RELIEF	Vitality Works, Inc	ca137d01-9feb-446a-8410-3d553e54ee50	2025-12-17	Warnings	Exact identifier ndc (package): 64616-069-02 ndc (package): 64616-069-01 ndc (product): 64616-069 ndc11 (package): 64616006902 ndc11 (package): 64616006901 spl id: 462ef671-8e94-9d8a-e063-6294a90ab347 spl set id: ca137d01-9feb-446a-8410-3d553e54ee50

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.