X OUT SPOT CORRECTOR- sulfur lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

THE PROACTIV COMPANY LLC

INN (International Name):

SULFUR

Composition:

SULFUR 6 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acne treatment cream for the management of acne.

Authorization status:

OTC monograph final

Summary of Product characteristics

X OUT SPOT CORRECTOR- SULFUR LOTION
THE PROACTIV COMPANY LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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X OUT SPOT CORRECTOR
_DRUG FACTS_
ACTIVE INGREDIENT
Sulfur 6%
PURPOS E
Acne treatment cream
US E
for the management of acne.
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
do not use this product more than three times per day.
skin irritation and dryness are 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.
avoid contact with eyes. If contact occurs, rinse thoroughly with
water.
DO NOT USE on
broken skin
large areas of the skin
STOP USE AND ASK A DOCTOR
If irritation becomes severe.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
_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
below.
cleanse 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.
®
INACTIVE INGREDIENTS
water, dicaprylyl carbonate, alcohol denat., neopentyl glycol
diheptanoate, glycerin, acacia senegal
gum, olive oil PEG-7 esters, butylene glycol, tocopheryl acetate,
melaleuca alternifolia (tea tree) leaf
oil, cymbopogon schoenanthus extract, geranium maculatum extract,
camellia sinensis leaf extract,
dipotassium glycyrrhizate, montmorillonite, pentylene glycol, ascorbyl
palmitate, ethylhexylglycerin,
butyl avoc