Label: DIFFERIN ACNE CLEARING BODY- salicylic acid aerosol, spray
- NDC Code(s): 0299-4132-00
- Packager: Galderma Laboratories, L.P.
- 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.
Updated May 6, 2022
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
• Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. • 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
- Questions or comments? 1-866-735-4137
- PRINCIPAL DISPLAY PANEL - 6 OZ bottle
INGREDIENTS AND APPEARANCE
DIFFERIN ACNE CLEARING BODY
salicylic acid aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0299-4132 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 2 g in 100 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Alcohol (UNII: 3K9958V90M) Glycolic Acid (UNII: 0WT12SX38S) Hamamelis Virginiana Top Water (UNII: NT00Y05A2V) Polysorbate 20 (UNII: 7T1F30V5YH) Ammonia (UNII: 5138Q19F1X) Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0299-4132-00 170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/01/2022 Labeler - Galderma Laboratories, L.P. (047350186) Establishment Name Address ID/FEI Business Operations Fruit of The Earth, Inc 080086802 manufacture(0299-4132)