SULFUR SPOT TREATMENT- sulfur gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)

Available from:

Face Reality, Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

for the treatment of acne

Authorization status:

OTC monograph final

Summary of Product characteristics

SULFUR SPOT TREATMENT- SULFUR GEL
FACE REALITY, INC
----------
SULFUR SPOT TREATMENT
_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_
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?_
1-866-477-3077
PACKAGE LABELING:70707-440-15
PACKAGE LABELING:70707-440-04
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
Face Reality, Inc
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ACACIA (UNII: 5C5403N26O)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALLANTOIN (UNII: 344S277G0Z)
BENZYL ALCOHOL (UNII: LK