Label: PUR 4-IN-1 CORRECTING PRIMER- salicylic acid emulsion
- NDC Code(s): 67345-0380-1, 67345-0380-2, 67345-0380-3
- Packager: Purminerals
- 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 November 3, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Uses
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Warnings
For external use only
- Keep out of reach of children. If swallowed, call a Poison Control Center or get medical help right away
- Skin irritation and dryness are more likely to occur when using another topical acne product at the same time. If irritation occurs, rinse thoroughly with water
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- For more severe cases, or if improvement is not apparent within 6-8 weeks, consult a health care professional.
Know Adverse Reaction(s): If you develop severe irritation, burning or itching of the skin, discontinue use and consult a health care professional.
- if you develop hives, swelling of the eyes and mouth, blistering or difficulty breathing, get medical help right away.
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Directions
- Clean the skin thoroughly before applying the product
For New Users
- Apply product to a small area once a day for three days to test if you are sensitive to this product, if not discomfort occurs, cover the entire affected area with a thin layer
- Start with one application daily, the gradually increase to two or three times daily if needed.
- If dryness or peeling occurs, reduce application to once a day or every other day.
- Keep carton fo additional directions and warning information
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Inactive Ingredients
Alteromonas Ferment Filtrate, Buddleja Officinalis Flower Extract, Butylene Glycol, Butyrospermum Parkii (Shea Butter) Extract, Camellia Sinensis Leaf Extract, Caprylyl Glycol, Ceramide AP, Charcoal Powder, Citric Acid, Decyl Glucoside, Dimethicone, Glycerin, Hexylene Glycol, Hydroxyethylcellulose, L-Lactic Acid, Niacinamide, Panax Ginseng Root Extract, Pentylene Glycol, Phenoxyethanol, Polyacrylate 13, Polyisobutene, Polymethylsilsesquioxane, Polysilicone-11, Polysorbate 20, Potassium Sorbate, Propanediol, Retinol, Sodium Hydroxide, Sodium Starch Octenylsuccinate, Water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PUR 4-IN-1 CORRECTING PRIMER
salicylic acid emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67345-0380 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 mL Inactive Ingredients Ingredient Name Strength ALTEROMONAS MACLEODII (UNII: BPX036043D) BUDDLEJA OFFICINALIS FLOWER (UNII: 274707Y672) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SHEA BUTTER (UNII: K49155WL9Y) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE AP (UNII: F1X8L2B00J) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) HEXYLENE GLYCOL (UNII: KEH0A3F75J) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) LACTIC ACID, L- (UNII: F9S9FFU82N) NIACINAMIDE (UNII: 25X51I8RD4) PANAX GINSENG ROOT WATER (UNII: P9T4K47OM0) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPANEDIOL (UNII: 5965N8W85T) RETINOL (UNII: G2SH0XKK91) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67345-0380-2 1 in 1 CARTON 01/01/2020 1 NDC:67345-0380-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:67345-0380-3 10 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 01/01/2020 Labeler - Purminerals (114450443)