FDA Label for Acne Free Sensitive Skin 24 Hr Acne Clearing System

View Indications, Usage & Precautions

Acne Free Sensitive Skin 24 Hr Acne Clearing System Product Label

The following document was submitted to the FDA by the labeler of this product Acnefree Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Salicylic acid 1.5%

Benzoyl peroxide 3%


Purpose



Acne treatment

Acne treatment


Use



for the treatment of acne

for the treatment of acne


Warnings



For external use only

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.

• 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.
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips, and mouth
• avoid contact with hair and dyed fabrics, which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.


Keep Out Of Reach Of Children.



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

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
• if bothersome dryness or peeling occurs, reduce application use
• may be used on chest or back

• 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
• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.


Other Information



store at 60°−95° F (15°−35° C)

store at 60°−95° F (15°−35° C)


Inactive Ingredients



water, sodium cocoyl isethionate, stearic acid, cocamidopropyl betaine, sodium lauroamphoacetate, disodium laureth sulfosuccinate, glycol distearate, polyacrylate-1 crosspolymer, benzyl alcohol, avena sativa (oat) kernel extract, sodium phytate, zinc PCA, glycerin, sorbic acid, ethyl vanillin, butylene glycol, sea whip extract, aminomethyl propanol

water, ethyl macadamiate, propanediol, glycerin, butylene glycol, polyacrylamide, phenoxyethanol, C13-14 isoparaffin, bisabolol, laureth-7, allantoin, melaleuca alternifolia (tea tree) leaf oil, methylisothiazolinone, sodium hyaluronate, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium hydroxide


Questions Or Comments?



1-888-768-2913

1-888-768-2913


Do Not Use



if you

• have very sensitive skin
• are sensitive to benzoyl peroxide


Stop Use And Ask A Doctor If



skin irritation becomes severe


Kit 80861-007-01




80861-008-01




80861-009-01




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