BENZAC- salicylic acid solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Galderma Laboratories, L.P.

INN (International Name):

SALICYLIC ACID

Composition:

SALICYLIC ACID .5 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Salicylic Acid 0.5%...Acne treatment • For the treatment of acne • Penetrates pores to eliminate most acne blemishes and help prevent new ones from forming

Authorization status:

OTC monograph final

Summary of Product characteristics

BENZAC- SALICYLIC ACID SOLUTION
GALDERMA LABORATORIES, L.P.
_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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BENZAC ACNE SOLUTIONS
BLEMISH CLEARING HYDRATOR
ACTIVE INGREDIENT..PURPOSE
Salicylic Acid 0.5%...Acne treatment
US ES
• For the treatment of acne
• Penetrates pores to eliminate most acne blemishes and help prevent
new ones from forming
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
• on damaged skin (cuts, abrasions, eczema, sunburned)
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.
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.
DO NOT USE AROUND EYE AREA. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH
WATER. IF IRRITATION DEVELOPS,
DISCONTINUE USE.
DIRECTIONS
• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer once or twice
daily
• because excesssive drying of the skin may occur, start with one
application daily, then gradually
increase to two times daily as needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to
once a day or every other day.»
DRUG FACTS (CONTINUED)
INACTIVE INGREDIENTS
®
Alcohol Denatured, Backhousia Citriodora Leaf Extract, Butyl
Avocadate, Butylene Glycol, C13-14
Isoparaffin, Caprylic/Capric Triglyceride, Chlorphenesin, Citric Acid,
Glycerin, Hydrolyzed Algin,
Isodecyl Neopentanoate, Laureth-7, Lonicera Caprifolium (Honeysuckle)
Flower Extract, Lonicera
Japonica (Honeysuckle) Flower Extract, Methylparaben, Phenoxyethanol,
Polyacrylamide, Potassium
Benzoate, Potassium Sorbate, Propylene Glycol, Santalum Album
(Sandalwood) Oil, Terminalia
Fe