FDA.reportPublic FDA data

Inflammation OTC

Manufacturer
Skin Deep
Effective date
2011-08-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:24

Label at a glance#

ProductInflammation OTC Bruise Relief
Active ingredientCamphor (Natural)
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with bruises

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a physician

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor (3.16%)

Purpose

OTC - PURPOSE SECTION

Counterirritant

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with bruises

Warning

WARNINGS SECTION

For external use only

Avoid contact with the eyes

If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician

Do not apply to wounds or damaged skin

Do not bandage tightly

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

In case of accidental ingestion seek professional assistance or contact a poison control center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, glycine soja (soybean) oil, glycerin, panthenol, alcohol, ascorbic acid, citrus medica limonum (lemon) peel extract, niacinamide, petasites japonicus (butterbur) root extract, glycereth-7 trimethyl ether, sodium polycrylate, c18-21 alkane, lactobacillus/bean seed extract/sodium glutamate ferment filtrate, uncaria tomentosa extract, calendula officinale (ginger) root extract, tocopherol, urea, yeast amino acid, arctium majus root (burdock) extract, trideceth-6, ruscus aculeatus root extract, inositol, taurine, trehalose, centipeda cunninghamii extract, saccharomyces/calcium ferment, saccharomyces/copper ferment, saccharomyces/manganese ferment, saccaromyces/zinc ferment, vitamin k, iodopropynyl butylcarbamate, phenoxyethanol

Questions and Comments

OTC - QUESTIONS SECTION

Store between 35 F and 80 F

call 1-912-236-9430 weekdays

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Inflammation OTC

Bruise Relief

Net wt 1 oz. (28.5 mL)

Manufacture by SkinDeep for SkinFit Distributors

Savannah, Georgia 31405

Tel: 912-236-9430

www.mwlabs.com

Inflammation OTC BoxInflammation OTC Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
435780camphor 3.5 % Topical LotionPSN1
1148418Inflammation OTC Bruise 3.5 % Topical LotionPSN1
1148418camphor 35 MG/ML Topical Lotion [Inflammation OTC Bruise]SBD1
435780camphor 35 MG/ML Topical LotionSCD1
435780camphor 3.5 % Topical LotionSY1
1148418Inflammation OTC Bruise 3.5 % Topical LotionSY1
1148418Inflammation OTC Bruise 35 MG/ML Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45156-5502-22019-10-29C16284748780-1960f7f55-d097-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45156-5502-1Inflammation OTCBruise Relief29 g in 1 TUBELOTION291
45156-5502-2Inflammation OTCBruise Relief1 in 1 BOXLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45156-5502INFLAMMATION OTC BRUISE RELIEF (CAMPHOR) LOTION [SKIN DEEP]1Legacy NDC, 2 package rows20110901_e61ead58-8a0d-4076-90dc-aa89bd2bcf3c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Camphor (Natural)ACTIVE INGREDIENTN20HL7Q9411
Camphor (Natural)ACTIVE MOIETYN20HL7Q9411
AlcoholINACTIVE INGREDIENT3K9958V90M1
Alpha-TocopherolINACTIVE INGREDIENTH4N855PNZ11
Arctium Lappa RootINACTIVE INGREDIENT597E9BI3Z31
Arnica Montana FlowerINACTIVE INGREDIENTOZ0E5Y15PZ1
Ascorbic AcidINACTIVE INGREDIENTPQ6CK8PD0R1
BetaineINACTIVE INGREDIENT3SCV180C9W1
Calendula Officinalis FlowerINACTIVE INGREDIENTP0M7O4Y7YD1
CarrageenanINACTIVE INGREDIENT5C69YCD2YJ1
Cat's ClawINACTIVE INGREDIENT9060PRM18Q1
DexpanthenolINACTIVE INGREDIENT1O6C93RI7Z1
GingerINACTIVE INGREDIENTC5529G5JPQ1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Green Tea LeafINACTIVE INGREDIENTW2ZU1RY8B01
InositolINACTIVE INGREDIENT4L6452S7491
Iodopropynyl ButylcarbamateINACTIVE INGREDIENT603P14DHEB1
Lecithin, SoybeanINACTIVE INGREDIENT1DI56QDM621
Lemon OilINACTIVE INGREDIENTI9GRO824LL1
NiacinamideINACTIVE INGREDIENT25X51I8RD41
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
PhytonadioneINACTIVE INGREDIENTA034SE78571
Ruscus Aculeatus RootINACTIVE INGREDIENTZW12V95I1Q1
Saccharomyces CerevisiaeINACTIVE INGREDIENT978D8U419H1
Soybean OilINACTIVE INGREDIENT241ATL177A1
TaurineINACTIVE INGREDIENT1EQV5MLY3D1
TrehaloseINACTIVE INGREDIENTB8WCK70T7I1
Trideceth-6INACTIVE INGREDIENT3T5PCR2H0C1
UreaINACTIVE INGREDIENT8W8T17847W1
WaterINACTIVE INGREDIENT059QF0KO0R1
WormwoodINACTIVE INGREDIENTF84709P2XV1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45156-550245156-5502-1, 45156-5502-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
Camphor (Natural)N20HL7Q941ACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Alcohol3K9958V90MIACT
Dexpanthenol1O6C93RI7ZIACT
Soybean Oil241ATL177AIACT
Ascorbic AcidPQ6CK8PD0RIACT
Lemon OilI9GRO824LLIACT
Lecithin, Soybean1DI56QDM62IACT
Niacinamide25X51I8RD4IACT
Cat's Claw9060PRM18QIACT
Calendula Officinalis FlowerP0M7O4Y7YDIACT
WormwoodF84709P2XVIACT
Green Tea LeafW2ZU1RY8B0IACT
Arnica Montana FlowerOZ0E5Y15PZIACT
Xanthan GumTTV12P4NEEIACT
Carrageenan5C69YCD2YJIACT
GingerC5529G5JPQIACT
Alpha-TocopherolH4N855PNZ1IACT
Urea8W8T17847WIACT
Saccharomyces Cerevisiae978D8U419HIACT
Arctium Lappa Root597E9BI3Z3IACT
Trideceth-63T5PCR2H0CIACT
Ruscus Aculeatus RootZW12V95I1QIACT
Betaine3SCV180C9WIACT
Inositol4L6452S749IACT
Taurine1EQV5MLY3DIACT
TrehaloseB8WCK70T7IIACT
PhytonadioneA034SE7857IACT
Iodopropynyl Butylcarbamate603P14DHEBIACT
PhenoxyethanolHIE492ZZ3TIACT

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 5 · 245 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RTABLET, ORALLY DISINTEGRATING / ORAL2.35 mgExact identifier — unii candidate
25 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
CarrageenanCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii candidate
10 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
CarrageenanCARRAGEENAN5C69YCD2YJPOWDER, FOR SUSPENSION / ORAL15 mgExact identifier — unii candidate
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
CarrageenanCARRAGEENAN5C69YCD2YJGRANULE, FOR SUSPENSION / ORAL161 mgExact identifier — unii candidate
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2 mgExact identifier — unii candidate
25 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RCAPSULE, DELAYED RELEASE / ORAL12 mgExact identifier — unii candidate
25 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RCONCENTRATE / ORAL6 mg/1mlExact identifier — unii candidate
25 equally ranked IID candidates
Lecithin, SoybeanSOYBEAN LECITHIN1DI56QDM62TABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
Lecithin, SoybeanSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
UreaUREA8W8T17847WDOUCHE / VAGINAL8 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
Soybean OilSOYBEAN OIL241ATL177AINJECTION, EMULSION / INTRAVENOUS107100 mgExact identifier — unii candidate
7 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
Lemon OilLEMON OIL, COLD PRESSEDI9GRO824LLCAPSULE / ORAL8.5 mgExact identifier — unii candidate
4 equally ranked IID candidates
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RSOLUTION / TOPICAL0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CarrageenanCARRAGEENAN5C69YCD2YJCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
10 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
UreaUREA8W8T17847WTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 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
0f21ff3e-6619-41ee-bde7-473b91cb55e4e61ead58-8a0d-4076-90dc-aa89bd2bcf3c2011-08-08WarningsExact identifier
spl id: 0f21ff3e-6619-41ee-bde7-473b91cb55e4
spl set id: e61ead58-8a0d-4076-90dc-aa89bd2bcf3c

Reported adverse events (FAERS/openFDA)#

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