Naturium Sulfur Spot Treatment 8%

Sulfur by

Drug Labeling and Warnings

Sulfur by is a Otc medication manufactured, distributed, or labeled by The Center Brands, DIMENSIONAL MERCHANDISING INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SULFUR- naturium sulfur spot treatment 8% liquid 
The Center Brands

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Naturium Sulfur Spot Treatment 8%

Active Ingredient
Purpose
Sulfur 8.0%....Acne treatment

Uses
Helps clear up acne
blemishes and helps
prevent new acne blemishes
from forming.

Warnings
For external use only.
When using this product
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.
Do not use on
broken skin
large areas of the skin
When using this product
apply only to areas with
acne
Avoid eye area.
In case of eye contact, flush
gently and thoroughly with
water.

Keep out of reach of
children.

When using this product
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.
Do not use on
broken skin
large areas of the skin

When using this product
apply only to areas with
acne
Avoid eye area.

Shake Well
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.
if going outside, apply sunscreen after using

this product. If irritation or sensitivity develops,
stop use and ask a doctor.

Other Information Sensitivity Test for a New User. Apply product
sparingly to one or two small affected areas
during the first 3 days. If no discomfort occurs,
follow the directions stated above.Store in
controlled temperatures (4-20°C/39-68°F).
Keep in a dark and dry place. Keep container
tightly closed.

Inactive Ingredients Aqua (Water), Kaolin, Aluminum Starch
Octenylsuccinate, Propanediol, Glyceryl
Stearate, Niacinamide, Acacia Senegal Gum,
Cetearyl Alcohol, Glycerin, Ganoderma Lucidum
Extract, Acetyl Glucosamine, Aloe Barbadensis
Leaf Juice, Tranexamic Acid, Citric Acid,
Xanthan Gum, Phenoxyethanol, Tocopheryl
Acetate, Ethylhexylglycerin, 1,2-Hexanediol,
Caprylyl Glycol, Potassium Sorbate, Sodium
Benzoate, Tocopherol.

When using this product
apply only to areas with
acne
Avoid eye area.

Shake Well
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.
if going outside, apply sunscreen after using

this product. If irritation or sensitivity develops,
stop use and ask a doctor.

SULFUR 
naturium sulfur spot treatment 8% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82800-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPANEDIOL (UNII: 5965N8W85T)
NIACINAMIDE (UNII: 25X51I8RD4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TOCOPHEROL (UNII: R0ZB2556P8)
ACACIA SENEGAL FLOWER (UNII: 72P931MTC2)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERIN (UNII: PDC6A3C0OX)
GANODERMA LUCIDUM WHOLE (UNII: J5P04QW0CF)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
TRANEXAMIC ACID (UNII: 6T84R30KC1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82800-002-01	15 g in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	06/17/2022	11/17/2023

Labeler - The Center Brands (076228814)

Establishment
Name	Address	ID/FEI	Business Operations
DIMENSIONAL MERCHANDISING INC		076693183	manufacture(82800-002)

Revised: 11/2023

Document Id: 0a5daa94-6939-01a4-e063-6294a90aed0f

34390-5

Set id: e33fb917-664e-8629-e053-2a95a90a52b6

Version: 2

Effective Time: 20231117