ACNE FREE SENSITIVE SKIN 24 HR ACNE CLEARING SYSTEM- salicylic acid, benzoyl peroxide 
AcneFree LLC

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Acne Free SENSITIVE SKIN 24 HR Acne Clearing System KIT

Drug Facts

Active ingredient

Salicylic acid 1.5%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

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.

Keep out of reach of children.

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

Other information

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

Questions or comments?

1-888-768-2913

Drug Facts

Active ingredient

Benzoyl peroxide 3%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use 

if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

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.
• 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.

Stop use and ask a doctor if

skin irritation becomes severe

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
• 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)

Inactive ingredients

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

KIT 80861-007-01

Kit01

80861-008-01

Label05Label07

80861-009-01

Label06

ACNE FREE SENSITIVE SKIN 24 HR ACNE CLEARING SYSTEM 
salicylic acid, benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80861-007
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80861-007-011 in 1 KIT12/01/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 21 BOTTLE 59 mL
Part 1 of 2
SALICYLIC ACID ACNE CLEANSER 
salicylic acid lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
OAT (UNII: Z6J799EAJK)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBIC ACID (UNII: X045WJ989B)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80861-008-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00612/01/2017
Part 2 of 2
SENSITIVE SKIN ACNE 
benzoyl peroxide lotion
Product Information
Item Code (Source)NDC:80861-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LEVOMENOL (UNII: 24WE03BX2T)  
LAURETH-7 (UNII: Z95S6G8201)  
ALLANTOIN (UNII: 344S277G0Z)  
TEA TREE OIL (UNII: VIF565UC2G)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GINGER (UNII: C5529G5JPQ)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80861-009-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00612/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00612/01/2017
Labeler - AcneFree LLC (122237140)

Revised: 12/2023
Document Id: 0d8026ea-575e-f19d-e063-6394a90a1c42
Set id: c9397a25-8fed-48d0-e053-2a95a90ab495
Version: 4
Effective Time: 20231227
 
AcneFree LLC