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NDC 00311-0725-30 ALMAY CLEAR COMPLEXION CONCEALER 2 mg/2mL Details

ALMAY CLEAR COMPLEXION CONCEALER 2 mg/2mL

ALMAY CLEAR COMPLEXION CONCEALER is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by ALMAY. The primary component is SALICYLIC ACID.

Product Information

NDC	00311-0725
Product ID	0311-0725_c3b57024-120f-390f-e053-2a95a90a6d35
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ALMAY CLEAR COMPLEXION CONCEALER
Proprietary Name Suffix	n/a
Non-Proprietary Name	SALICYLIC ACID
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	2
Active Ingredient Units	mg/2mL
Substance Name	SALICYLIC ACID
Labeler Name	ALMAY
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358H
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00311-0725-30 (00311072530)

Pricing Information	N/A
NDC Package Code	0311-0725-30
Billing NDC	00311072530
Package	9 mL in 1 CONTAINER (0311-0725-30)
Marketing Start Date	2021-03-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c3b57024-120e-390f-e053-2a95a90a6d35 Details

ACTIVE INGREDIENT

Active ingredient Purpose

Salicylic Acid 2.0%................................................Acne Treatment

OTHER INGREDIENTS

AQUA/WATER/EAU, CYCLOPENTASILOXANE, GLYCERIN, KAOLIN, DIMETHICONE, BORON NITRIDE, TRIBEHENIN, PEG/

PPG-18/18 DIMETHICONE, TRIMETHYLSILOXYSILICATE, METHYL METHACRYLATE CROSSPOLYMER, CETYL PEG/PPG-10/1 DIMETHICONE, PEG-10 DIMETHICONE, HYDROLYZED VEGETABLE PROTEIN, POLYETHYLENE, ALOE BARBADENSIS LEAF JUICE, MARIS SAL/SEA SALT/SEL MARIN, SILICA, 1,2-HEXANEDIOL, ALPHA-GLUCAN OLIGOSACCHARIDE, CAPRYLYL GLYCOL, LACTOBACILLUS, MALTODEXTRIN, PERLITE, POLYISOBUTENE, POLYMNIA SONCHIFOLIA ROOT JUICE, TETRASODIUM EDTA, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, TRISILOXANE, PHENOXYETHANOL. MAY

CONTAIN: [+/- : IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), TITANIUM DIOXIDE (CI 77891), ZINC OXIDE (CI 77947).]

USE

Helps clear and prevent new acne blemishes

WARNING

• Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

DIRECTIONS

• Clean skin thoroughly before applying this product

• Cover 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

• 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 above

WARNINGS

When using this product

• Skin irritation and dryness is more likely to occur if you use another topical acne mediation at the same time. If irritation occurs, only use one topical acne medication at a time.

• Avoid contact with eyes. If contact occurs, flush thoroughly with water

SPL UNCLASSIFIED SECTION

Anti-Acne Treatment

ART

INGREDIENTS AND APPEARANCE

ALMAY CLEAR COMPLEXION CONCEALER

salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0311-0725
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 mg in 2 mL

Ingredient Name	Strength
Inactive Ingredients
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
WATER (UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
BORON NITRIDE (UNII: 2U4T60A6YD)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SEA SALT (UNII: 87GE52P74G)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PERLITE (UNII: 0SG101ZGK9)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
ZINC OXIDE (UNII: SOI2LOH54Z)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
SMALLANTHUS SONCHIFOLIUS LEAF (UNII: AX57ELY8YM)
TRISILOXANE (UNII: 9G1ZW13R0G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE SODIUM (UNII: MP1J8420LU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
KAOLIN (UNII: 24H4NWX5CO)
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHICONE (UNII: 92RU3N3Y1O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0311-0725-30	9 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/05/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	03/05/2021

Labeler - ALMAY (064988652)

Name	Address	ID/FEI	Business Operations
Establishment
REVLON		809725570	manufacture(0311-0725)

Revised: 6/2021

Document Id: c3b57024-120f-390f-e053-2a95a90a6d35

Set id: c3b57024-120e-390f-e053-2a95a90a6d35

Version: 1

Effective Time: 20210601