SEBOBALANCE Spot Control

Manufacturer
Laboratoire Dr. Renaud
Effective date
2010-06-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:26:01

Label at a glance#

ProductSEBOBALANCE Spot Control
Active ingredientSALICYLIC ACID
Label structure3 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1% w/w.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER/EAU • ALCOHOL DENAT • SORBITOL • METHYL GLUCETH 20 • GLYCOLIC ACID • GLYCERIN •
ALPHA-GLUCAN OLIGOSACCHARIDE • SODIUM CITRATE • BUTYLENE GLYCOL • PROPYLENE GLYCOL • SODIUM HYDROXIDE • AMYLOPECTIN • XANTHAN GUM • DEXTRIN • HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT • ARGININE • CELLULOSE GUM • ALLANTOIN • PEUMUS BOLDUS LEAF EXTRACT • ASCOPHYLLUM NODOSUM EXTRACT • ANTHEMIS NOBILIS FLOWER EXTRACT • CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT • CENTAUREA CYANUS FLOWER EXTRACT • TILIA VULGARIS FLOWER EXTRACT • CALENDULA OFFICINALIS FLOWER EXTRACT • HYPERICUM PERFORATUM EXTRACT • ASPARAGOPSIS ARMATA EXTRACT • ETHYLHEXYLGLYCERIN • PHENOXYETHANOL •

OTC - PURPOSE SECTION

For the treatment of acne. Dries and clears acne pimples, blackheads and whiteheads and allows skin to heal.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Morning and evening, after a thorough cleansing of the skin, apply SeboBalance Spot Control
Gel locally on cutanous imperfections. Then apply the usual day or night cream. Renew application 1 to 3 times daily.

WARNINGS

WARNINGS SECTION

For external use only. Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Avoid direct contact with the eyes. If product gets into the eyes, rinse liberally with water. Discontinue use if skin irritation develops or increases. If irritation persists, consult a doctor. This product contains alpha-hydroxy-acids (AHA) which may increase sensitivity to the sun and lead to skin burn. Reduce sun exposure and use a sunblock during the use of this product and the week following its use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton label

image of carton label
image of carton label


Image of bottle label
image of bottle label
image of bottle label

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Enter section text here

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251380salicylic acid 1 % Topical GelPSN4
1020053SeboBalance Spot Control 1 % Topical GelPSN4
1020053salicylic acid 0.01 MG/MG Topical Gel [Sebobalance]SBD4
251380salicylic acid 0.01 MG/MG Topical GelSCD4
251380salicylic acid 1 % Topical GelSY4
1020053Sebobalance 0.01 MG/MG Topical GelSY4
1020053Sebobalance Spot Control 1 % Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62499-384-112019-10-29C16284748780-1960f7f55-d9e5-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62499-384-07SEBOBALANCE Spot Control8 g in 1 BOTTLE, WITH APPLICATORGEL84
62499-384-11SEBOBALANCE Spot Control1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62499-384SEBOBALANCE SPOT CONTROL (SALICYLIC ACID) GEL [LABORATOIRE DR. RENAUD]4Legacy NDC, 2 package rows20101007_8e614b35-b63a-4b0f-a0a4-3d8225ac23e2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ4
ALCOHOLINACTIVE INGREDIENT3K9958V90M4
ALLANTOININACTIVE INGREDIENT344S277G0Z4
AMYLOPECTININACTIVE INGREDIENT4XO4QFV7774
ARGININEINACTIVE INGREDIENT94ZLA3W45F4
ASCOPHYLLUM NODOSUMINACTIVE INGREDIENT168S4EO8YJ4
ASPARAGOPSIS ARMATAINACTIVE INGREDIENT2936KN6I1G4
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA4
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3114
CENTAUREA CYANUS FLOWERINACTIVE INGREDIENTQZ239038YC4
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OG4
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38S4
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKINACTIVE INGREDIENTT7S323PKJS4
HYPERICUM PERFORATUMINACTIVE INGREDIENTXK4IUX8MNB4
METHYL GLUCETH-20INACTIVE INGREDIENTJ3QD0LD11P4
PEUMUS BOLDUS LEAFINACTIVE INGREDIENTQ4EWM09M3O4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I4
SORBITOLINACTIVE INGREDIENT506T60A25R4
TILIA CORDATA FLOWERINACTIVE INGREDIENTCFN6G1F6YK4
WATERINACTIVE INGREDIENT059QF0KO0R4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE4

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62499-38462499-384-07, 62499-384-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 527 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / ORAL9120 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / SUBCUTANEOUSNAExact identifier — unii candidate
174 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAVITREAL0.5 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBCUTANEOUS31.45 mgExact identifier — unii candidate
174 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR25 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISWAB / TOPICAL0.01 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / RECTALNAExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / NASAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION/ DROPS / OPHTHALMIC2 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / URETHRALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ENTERAL2920 mgExact identifier — unii candidate
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / RECTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GRANULE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IEMULSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IAEROSOL, METERED / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE / ORAL160 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER, FOR SOLUTION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM, AUGMENTED / TOPICAL6 mgExact identifier — unii candidate
174 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRA-ARTICULAR25 mgExact identifier — unii candidate
44 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
ARGININEARGININE94ZLA3W45FINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
11 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates

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
a1bf5e85-1fd0-4050-8071-f15f3bc6042b8e614b35-b63a-4b0f-a0a4-3d8225ac23e22010-06-30WarningsExact identifier
spl id: a1bf5e85-1fd0-4050-8071-f15f3bc6042b
spl set id: 8e614b35-b63a-4b0f-a0a4-3d8225ac23e2

Reported adverse events (FAERS/openFDA)#

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