24 HOUR SENSITIVE SKIN ACNE CLEARING SYSTEM- salicylic acid kit

24 Hour Sensitive Skin Acne Clearing System by

Drug Labeling and Warnings

24 Hour Sensitive Skin Acne Clearing System by is a Otc medication manufactured, distributed, or labeled by Acne Free LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Salicylic acid 1.5%

Purpose

Acne treatment

Use

for treatment of acne

Warnings

For external use only

When using this product
Avoid contact with eyes

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.

If contact occurs, rinse thoroughly with water

Keep out of reach of children

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

When using this product

skin initation and dryness is more likely to occur r
you use another topical acne medic,rnon at the same time. If irritation occurs, only use one topical
acne medication at a time.

Directions

• Use every morning and evening
• Apply a dime-size amount to damp skin and gently massage, avoiding eye area
• Rinse well
• Use wash on entire affected area one to two times daily
• May be used on chest or back

Inactive ingredients

water, cocamidopropyl betaine, sodiumcocoyl
isethionate, glycerin, coco-glucoside, acrylates/Cl 0-30 alkyl acrylate crosspolymer, sodium
hydroxide, sodium benzoate, guar hydroxypropyltrimonium chloride, tocopheryl acetate, sodium
hyaluronate, ascorbyl palmitate, citric acid, gluconolactone, chamomilla recutita (matricaria)
flower extract, avena sativa (oat) bran extract, citrus aurantium dulcis (orange) peel extract

Questions or comments?

1-888-768-2913

Active ingredient

Salicylic acid 1.5%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

1. When using this product
2. Avoid contact with eyes

1. skin initation and dryness is more likely to occur r
you use another topical acne medic,rnon at the same time. If irritation occurs, only use one topical
acne medication at a time.

2. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor if skin irritation occurs.

Directions

Cleanse thoroughly before applying treatment.
Apply a thin layer to the affected area one to three times daily.
Because excess drying of the skin may occur, start with one application daily, then gradually
increase to two to three times daily if needed or as directed by a doctor.
If bothersome dryness or peeling occurs, reduce to once a day or even every other day.
May be used on chest or back.

Inactive ingredients

water, Cl2-15 alkyl benzoate, glycerin, squalane,
polyacrylamide, glyceryl stearate, PEG-100 stearate, cetyl alcohol, phenoxyethanol, cetearyl
alcohol, Cl3-14 isoparaffin, arachidyl alcohol, pyrus malus (apple) fruit extract, behenyl alcohol,
ceteareth-20, sodium hydroxide, laureth-7, arachidyl glucoside, polyglyceryl-3 cocoate,
polyglyceryl-4 caprate, polyglyceryl-6 caprylate, polyglyceryl-6 ricinoleate, ethylhexylglycerin,
3-o-ethyl ascorbic acid, tocopheryl acetate, avena saliva (oat) kernel extract, sodium hyaluronate,
chamomilla recutita (matricaria) flower extract

Questions or comments?

1-888-768-2913

Kit 80861-118

Acne cleanser 80861-008

Acne lotion 80861-119

INGREDIENTS AND APPEARANCE

24 HOUR SENSITIVE SKIN ACNE CLEARING SYSTEM 
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80861-118

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80861-118-01	1 in 1 KIT; Type 0: Not a Combination Product	07/14/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	59 mL
Part 2	1 BOTTLE	118 mL

Part 1 of 2

SALICYLIC ACID 
salicylic acid lotion

Product Information
Item Code (Source)	NDC: 80861-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POLYGLYCERYL-6 CAPRYLATE (UNII: DGV8R54VG7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
CETYL ALCOHOL (UNII: 936JST6JCN)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PYRUS MALUS (APPLE) FRUIT (UNII: B423VGH5S9)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
LAURETH-7 (UNII: Z95S6G8201)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
AVENA SATIVA (OAT) KERNEL OIL (UNII: 3UVP41R77R)
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARETH-20 (UNII: YRC528SWUY)
POLYGLYCERYL-3 STEARATE (UNII: 8FDA8C98S3)
POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)
POLYGLYCERYL-6 RICINOLEATE (UNII: 8X57R183N7)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PEG-100 STEARATE (UNII: YD01N1999R)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80861-119-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	07/14/2025

Part 2 of 2

SALICYLIC ACID ACNE CLEANSER 
salicylic acid lotion

Product Information
Item Code (Source)	NDC: 80861-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCO-GLUCOSIDE (UNII: ICS790225B)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
CITRIC ACID (UNII: 2968PHW8QP)
AVENA SATIVA (OAT) BRAN (UNII: KQX236OK4U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL (UNII: AKN3KSD11B)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80861-008-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	07/14/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	07/14/2025

Labeler - Acne Free LLC (122237140)