DailyMed - SPOT ACNE TREATMENT OIL FREE 0.75OZ- salicylic acid cream

NDC Code(s): 57337-168-01
Packager: Rejoice International Corp.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated September 2, 2024

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Active ingredient
Salicylic Acid 2%

Salicylic Acid 2%
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Purpose
Acne Medication

Acne Medication
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Use
For the treatment of acne

For the treatment of acne
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Warnings
When using this product - skin irritation and dryness is more likely to occur if you use another topical cene medication at the same time. If irritation occurs, only use one topical acne ...
When using this product
- skin irritation and dryness is more likely to occur if you use another topical cene medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Do not use if you

Do not use if you have very sentitive skin.
When using this product
- avoid unnessary sun exposure and use sunscreen.
- avoid contact with 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 a lower concentration.
Stop use and ask a doctor if
- irritation becomes severer.
Keep out of reach of children

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

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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 ...
- 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 directed by a doctor.
- If some drynesss 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.
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Other information
Store at 20°C-25°C (68°F-77°F)

Store at 20°C-25°C (68°F-77°F)
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Inactive gredients
Water - Alcohol - Phenyl Trimethicone - C13-14 Isoparaffin - Laureth-7 - Polyacrylamide - Glycerin - Hamamelis Virginiana (Witch Hazel) Exact - Polysorbate 20 - Phenoxyethanol - Propylene Glycol - Xanthan ...

Water

Alcohol

Phenyl Trimethicone

C13-14 Isoparaffin

Laureth-7

Polyacrylamide

Glycerin

Hamamelis Virginiana (Witch Hazel) Exact

Polysorbate 20

Phenoxyethanol

Propylene Glycol

Xanthan Gum

Fragrance

Cyclopentasiloxane

C12-15 Alkyl Lactate

Cetyl Lactate,

PPG-2 Isoceteth-20 Acetate

Myristamidopropyl PG-dimonium Chloride Phosphate

Benzalkonium Chloride,

Disodium EDTA,

Butylene Glycol,

Capryloyl Glycine,

Sarcosine

Cinnamomum Zeylanicum Bark Extract,

Cedrus Atantica Bark Extract,

Portulaca Oleracea Extact

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INGREDIENTS AND APPEARANCE

Product Information

SPOT ACNE TREATMENT OIL FREE 0.75OZ salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57337-168
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PURSLANE (UNII: M6S840WXG5)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CINNAMON BARK OIL (UNII: XE54U569EC)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
LAURETH-7 (UNII: Z95S6G8201)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MYRISTAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: E4821CQM1I)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CETYL LACTATE (UNII: A7EVH2RK4O)
PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
XANTHAN GUM (UNII: TTV12P4NEE)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)
SARCOSINE (UNII: Z711V88R5F)
GLYCERIN (UNII: PDC6A3C0OX)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57337-168-01	21 g in 1 TUBE; Type 0: Not a Combination Product	09/02/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M006	09/02/2024

Labeler - Rejoice International Corp. (078741245)

Name	Address	ID/FEI	Business Operations
Establishment
China Ningbo Shangge Cosmetics Technology Corp.		529287434	manufacture(57337-168)

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	RxCUI	RxNorm NAME	RxTTY
1	317152	salicylic acid 2 % Topical Cream	PSN
2	317152	salicylic acid 20 MG/ML Topical Cream	SCD
3	317152	salicylic acid 2 % Topical Cream	SY

Label: SPOT ACNE TREATMENT OIL FREE 0.75OZ- salicylic acid cream

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Drug Label Information

When using this product

Do not use if you

When using this product

Stop use and ask a doctor if

Keep out of reach of children

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Safety

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More Info on this Drug

Label: SPOT ACNE TREATMENT OIL FREE 0.75OZ- salicylic acid cream

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

When using this product

Do not use if you

When using this product

Stop use and ask a doctor if

Keep out of reach of children

Find additional resources

Safety

Related Resources

More Info on this Drug

SPOT ACNE TREATMENT OIL FREE 0.75OZ- salicylic acid cream

Number of versions: 1

SPOT ACNE TREATMENT OIL FREE 0.75OZ- salicylic acid cream

SPOT ACNE TREATMENT OIL FREE 0.75OZ- salicylic acid cream

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SPOT ACNE TREATMENT OIL FREE 0.75OZ- salicylic acid cream

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.