PUR 4-IN-1 CORRECTING PRIMER- salicylic acid emulsion

PUR 4-in-1 Correcting Primer by

Drug Labeling and Warnings

PUR 4-in-1 Correcting Primer by is a Otc medication manufactured, distributed, or labeled by Purminerals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Salicylic Acid 1.0% w/w Purpose: Acne Medicaiton

Acne Medication

Uses

• For the treatment of acne

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.

When using this product

• 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.

Keep out of reach of children.

Keep out of reach of children. If swallowed, call a Poison Control Center or get medical help right away

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

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

INGREDIENTS AND APPEARANCE

PUR 4-IN-1 CORRECTING PRIMER 
salicylic acid emulsion

Product 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)