Acne Free Sensitive Skin 24 Hr Acne Clearing System Kit
FDA Label NDC 80861-007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acnefree Llc for the product Acne Free Sensitive Skin 24 Hr Acne Clearing System (NDC 80861-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, when using this product, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

Kit01 (Kit01)

Kit01 (Kit01)

80861-008-01

Label05 (Label05)

Label05 (Label05)

Label07 (Label07)

Label07 (Label07)

80861-009-01

Label06 (Label06)

Label06 (Label06)

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