FDA.reportPublic FDA data

Drug Facts

Manufacturer
L'Oreal USA Products Inc | RNA Pharma, LLC
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:49:33

Label at a glance#

ProductThayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Balm
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

• for the treatment of acne • clears acne blemishes and allows skin to heal • helps prevent the development of new acne blemishes

Dosage and administration

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

Storage and handling

store at 15°-30° C (59°-86° F) away from direct sunlight

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION


Salicylic acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

• for the treatment of acne
• clears acne blemishes and allows skin to heal
• helps prevent the development of new acne blemishes

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

store at 15°-30° C (59°-86° F) away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, helianthus annuus (sunflower) seed oil, stearic acid, glyceryl stearate, PEG-100 stearate, beeswax, hamamelis virginiana (witch hazel)
bark/leaf/twig extract, aloe barbadensis leaf extract, phenoxyethanol, ethylhexylglycerin, aminomethyl propanol, xanthan gum, carrageenan,
melaleuca alternifolia (tea tree) leaf oil, cymbopogon flexuosus (lemongrass) oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

image of a label
image of a label
image of a label
image of a label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN4
346298salicylic acid 0.02 MG/MG Topical GelSCD4
346298salicylic acid 2 % Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-530-01Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Balm118 mL in 1 TUBEGEL1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-530THAYERS SINCE 1847 NATURAL REMEDIES BLEMISH CLEARING WITCH HAZEL ALOE VERA FORMULA BALM (SALICYLIC ACID) GEL [L'OREAL USA PRODUCTS INC]4Current NDC, Legacy NDC, 1 package rows20250101_0c902cfa-d98a-42c3-967b-5a7c51a65249.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-53049967-530-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
SUNFLOWER OIL3W1JG795YIIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL DISTEARATE73071MW2KMIACT
PEG-100 STEARATEYD01N1999RIACT
YELLOW WAX2ZA36H0S2VIACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
XANTHAN GUMTTV12P4NEEIACT
CARRAGEENAN5C69YCD2YJIACT
TEA TREE OILVIF565UC2GIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula BalmSALICYLIC ACIDL'Oreal USA Products Inc0c902cfa-d98a-42c3-967b-5a7c51a652492024-12-30WarningsExact identifier
ndc (package): 49967-530-01
ndc (product): 49967-530
ndc11 (package): 49967053001
spl id: a65c3c45-5ec2-4471-ae23-3b0f76d72cce
spl set id: 0c902cfa-d98a-42c3-967b-5a7c51a65249

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.