SULFUR SPOT TREATMENT- sulfur gel

Sulfur Spot Treatment by

Drug Labeling and Warnings

Sulfur Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Face Reality, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sulfur 6%

Purpose

Acne Treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use

• on broken skin
• on large areas of skin

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.
• apply only to areas with acne

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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

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

Inactive ingredients

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

Questions or Comments?

1-866-477-3077

Package Labeling: 70707-440-15

Package Labeling: 70707-440-04

INGREDIENTS AND APPEARANCE

SULFUR SPOT TREATMENT 
sulfur gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70707-440
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
ALLANTOIN (UNII: 344S277G0Z)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70707-440-15	1 in 1 BOX	01/08/2020
1		44 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70707-440-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/08/2020

Labeler - Face Reality, Inc (602958071)