Sulfur Spot Treatment

Manufacturer: Face Reality, Inc
Effective date: 2024-12-09
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:41:28

Label at a glance#

ProductSulfur Spot Treatment

Active ingredientSULFUR

Label structure9 sections

Dosage and administration

clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times 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

Contacts and useful links#

PhoneLabel contact1-866-477-3077

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur 6%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on broken skin
on large areas of skin

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.
apply only to areas with acne

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a 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 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

SPL UNCLASSIFIED SECTION

Store at room temperature. Keep away from heat or direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Butylene Glycol, Acacia Senegal Gum, Carbomer, Phenoxyethanol, Bisabolol (L-alpha), Allantoin, Benzyl Alcohol, Glycerin, Caprylhydroxamic Acid, Dextran, Sodium Hydroxide, Ethylhexylglycerin, Palmitoyl Tripeptide-8.

Questions or Comments?

OTC - QUESTIONS SECTION

1-866-477-3077

Package Labeling:70707-440-15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube

Package Labeling:70707-440-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2273805	sulfur 6 % Topical Gel	PSN	4
2273805	sulfur 0.06 MG/MG Topical Gel	SCD	4
2273805	sulfur 6 % Topical Gel	SY	4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70707-440-04	Sulfur Spot Treatment	118 mL in 1 BOTTLE	GEL	118	4
70707-440-15	Sulfur Spot Treatment	44 mL in 1 TUBE	GEL	44	4
70707-440-15	Sulfur Spot Treatment	1 in 1 BOX	GEL	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70707-440	SULFUR SPOT TREATMENT (SULFUR) GEL [FACE REALITY, INC]	4	Current NDC, Legacy NDC, 3 package rows	20241210_921e948d-a8c7-4527-9257-4b91dee8fcff.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Sulfur Spot Treatment
SULFUR
BUTYLENE GLYCOL
ACACIA
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
PHENOXYETHANOL
WATER
ALLANTOIN
BENZYL ALCOHOL
GLYCERIN
CAPRYLHYDROXAMIC ACID
SODIUM HYDROXIDE
ETHYLHEXYLGLYCERIN
PALMITOYL TRIPEPTIDE-8

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70707-440	70707-440-15, 70707-440-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BUTYLENE GLYCOL	3XUS85K0RA	IACT
ACACIA	5C5403N26O	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
WATER	059QF0KO0R	IACT
ALLANTOIN	344S277G0Z	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
GLYCERIN	PDC6A3C0OX	IACT
CAPRYLHYDROXAMIC ACID	UPY805K99W	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
PALMITOYL TRIPEPTIDE-8	55HZC7YQA7	IACT
SULFUR	70FD1KFU70	ACTIB

Source Document#

Source XML

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
Sulfur Spot Treatment	SULFUR	Face Reality, Inc	921e948d-a8c7-4527-9257-4b91dee8fcff	2024-12-09	Warnings	Exact identifier ndc (package): 70707-440-04 ndc (package): 70707-440-15 ndc (product): 70707-440 ndc11 (package): 70707044004 ndc11 (package): 70707044015 spl id: 28da58df-4226-e6db-e063-6394a90aced8 spl set id: 921e948d-a8c7-4527-9257-4b91dee8fcff

Reported adverse events (FAERS/openFDA)#

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