SULFUR ACNE FOAMING CLEANSER- sulfur cream

Sulfur Acne Foaming Cleanser by

Drug Labeling and Warnings

Sulfur Acne Foaming Cleanser by is a Otc medication manufactured, distributed, or labeled by Acne Free, LLC, Universal Packaging Systems, INC, dba Paklab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sulfur 3.5 percent

Purpose

Acne Treatment

Warnings

For external use only

Do not use on

broken skin

large areas of skin

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

Keep out of reach of children

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

Directions

use every morning and evening

apply a dime-size amount to damp skin and gently massage, avoiding the eye area

rinse well

use wash on entire affected area one to two times daily

may be used on chest or back

Other Information

store at 59˚-95˚ F (15˚-35˚ C

Inactive Ingredients

water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, acacia senegal gum, phenoxyethanol, caprylyl glycol, citric acid, citrus limon (lemon) peel oil, limonene, potassium hydroxide, ethylhexylglycerin, hexylene glycol, sodium hyaluronate, niacinamide, sodium sulfate, avena sativa (oat) bran extract, sodium lauroyl lactylate, glycolic acid, calendula officinalis flower extract, ceramide NP, ceramide AP, phytosphingosine, cholesterol, carbomer, ceramide EOP

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SULFUR ACNE FOAMING CLEANSER 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80861-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	0.001 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white (cream)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80861-113-01	1 g in 1 TUBE; Type 0: Not a Combination Product	06/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	06/22/2023

Labeler - Acne Free, LLC (122237140)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, INC, dba Paklab		177711082	manufacture(80861-113)