Label: NEUTROGENA STUBBORN BODY ACNE TREATMENT- salicylic acid spray
- NDC Code(s): 69968-0758-6
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 9, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
For external use only. Flammable: Keep away from fire or flame.
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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 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.
- Inactive ingredients
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Other information
- Store at room temperature.
- Sunburn Alert:This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 186 mL Bottle Label
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INGREDIENTS AND APPEARANCE
NEUTROGENA STUBBORN BODY ACNE TREATMENT
salicylic acid sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0758 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SODIUM CITRATE (UNII: 1Q73Q2JULR) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) WATER (UNII: 059QF0KO0R) PPG-5-CETETH-20 (UNII: 4AAN25P8P4) C12-15 ALKYL LACTATE (UNII: GC844VRD7E) CETYL LACTATE (UNII: A7EVH2RK4O) SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCOLIC ACID (UNII: 0WT12SX38S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0758-6 162 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/01/2022 Labeler - Johnson & Johnson Consumer Inc. (118772437)