Label at a glance#

ProductSoothion Acne Treatment Formula

Active ingredientSALICYLIC ACID

Label structure9 sections

Indications and uses

For the treatment of Acne. Clears up acne pimples, blackheads and whiteheads and allows skin to heal.

Dosage and administration

clean the skin thoroughly before applying this product. cover the entire affected area with a thin layer one to three times a daily. because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Storage and handling

Store in a cool, dry place below 77°F Protect from heat and light

Contacts and useful links#

PhoneLabel contact(866) 528-3721

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 1%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of Acne.
Clears up acne pimples, blackheads and whiteheads and allows skin to heal.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

clean the skin thoroughly before applying this product.
cover the entire affected area with a thin layer one to three times a daily.
because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

STORAGE AND HANDLING SECTION

Store in a cool, dry place below 77°F
Protect from heat and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

melaleuca alternifolia leaf, polyacrylic acid, water

DESCRIPTION SECTION

Manufactured for Electrolyzed Innovations, LLC
(866) 528-3721 2214 Wilshire Dr, Piqua OH 45356 USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ion Infused

Acne Treatment Formula

Soothion

Ion Disperson Formula Designed to Clear Up

Acne
Pimples
Blemishes
Whiteheads
Blackheads

Net Wt. 8 oz (240 mL) Made in USA

Soothion Acne Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
245199	salicylic acid 1 % Topical Lotion	PSN	2
245199	salicylic acid 10 MG/ML Topical Lotion	SCD	2
245199	salicylic acid 1 % Topical Lotion	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69031-005-08	2022-01-28	C162847	48780-1	d6a99b39-ecad-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69031-005-08	Soothion Acne Treatment Formula	226 g in 1 BOTTLE	LOTION	226		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69031-005	SOOTHION ACNE TREATMENT FORMULA (SALICYLIC ACID) LOTION [ELECTROLYZED INNOVATIONS, LLC]	2	Legacy NDC, 1 package rows	20191224_317ee6b7-995f-48c7-882c-a4a2f7938ae7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	1
MELALEUCA ALTERNIFOLIA LEAF	INACTIVE INGREDIENT	G43C57162K	1
POLYACRYLIC ACID (250000 MW)	INACTIVE INGREDIENT	9G2MAD7J6W	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

Soothion Acne Treatment Formula
Salicylic Acid
MELALEUCA ALTERNIFOLIA LEAF
POLYACRYLIC ACID (250000 MW)
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69031-005	69031-005-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MELALEUCA ALTERNIFOLIA LEAF	G43C57162K	IACT
POLYACRYLIC ACID (250000 MW)	9G2MAD7J6W	IACT
WATER	059QF0KO0R	IACT
SALICYLIC ACID	O414PZ4LPZ	ACTIB

Source Document#

Source XML

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 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYACRYLIC ACID (250000 MW)	POLYACRYLIC ACID (250000 MW)	9G2MAD7J6W	SYSTEM / TOPICAL	196 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
POLYACRYLIC ACID (250000 MW)	POLYACRYLIC ACID (250000 MW)	9G2MAD7J6W	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 2 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
9a6688da-92a4-2d72-e053-2995a90a536c			317ee6b7-995f-48c7-882c-a4a2f7938ae7	2019-12-23	Warnings	Exact identifier spl id: 9a6688da-92a4-2d72-e053-2995a90a536c spl set id: 317ee6b7-995f-48c7-882c-a4a2f7938ae7

Reported adverse events (FAERS/openFDA)#

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