MEIJER ACNE SPOT TREATMENT- salicylic acid gel

Meijer by

Drug Labeling and Warnings

Meijer by is a Otc medication manufactured, distributed, or labeled by MEIJER DISTRIBUTION, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Meijer Acne Spot Treatment - Oil Free - Drug Facts

Active Ingredient

Salicylic acid 2.0%

Purpose

Acne Medication

INDICATIONS & USAGE

Uses For the treatment of acne.

Warnings

For external use only.

STORAGE AND HANDLING

FLAMMABLE: Keep away from spark, heat or flame.

WHEN USING

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

KEEP OUT OF REACH OF CHILDREN

Directions

• Cleanse skin thoroughly before applying 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 if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

SPL UNCLASSIFIED SECTION

Other information

May stain some fabrics.

Inactive ingredients

alcohol denat., ammonium hydroxide, benzalkonium chloride, butylene glycol, C12-15 alkyl lactate, C13-14 isoparaffin, capryloyl glycine, cedrus atlantica bark extract, cetyl lactate, cinnamomum zeylanicum bark extract, cocamidopropyl PG-dimonium chloride phosphate, cyclopentasiloxane, dehydroxanthan gum, ethylparaben, fragrance, glycerin, hamamelis virginiana (witch hazel) extract, hexylene glycol, laureth-7, methylparaben, phenethyl dimethicone, phenoxyethanol, polyacrylamide, polysorbate 20, portulaca oleracea extract, PPG-2 isoceteth-20 acetate, propylparaben, sarcosine, tetrasodium EDTA, water

PRINCIPAL DISPLAY PANEL

Meijer Acne Spot Treatment Oil Free

1 tube in a carton

0.75 FL OZ (22.1)

NDC: 41250-956-51

INGREDIENTS AND APPEARANCE

MEIJER  ACNE SPOT TREATMENT
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-956
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
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
CETYL LACTATE (UNII: A7EVH2RK4O)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
LAURETH-7 (UNII: Z95S6G8201)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)
GLYCERIN (UNII: PDC6A3C0OX)
CINNAMON BARK OIL (UNII: XE54U569EC)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SARCOSINE (UNII: Z711V88R5F)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PURSLANE (UNII: M6S840WXG5)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALCOHOL (UNII: 3K9958V90M)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
AMMONIA (UNII: 5138Q19F1X)
ETHYLPARABEN (UNII: 14255EXE39)
EDETATE SODIUM (UNII: MP1J8420LU)
CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-956-51	1 in 1 CARTON	08/08/2019
1		22.1 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/08/2019

Labeler - MEIJER DISTRIBUTION, INC (006959555)

Registrant - Fruit Of The Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(41250-956)