FDA.reportPublic FDA data

Inflammation OTC

Manufacturer
Skin Deep
Effective date
2011-08-16
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 Deep Pain Care Cold
Active ingredientCamphor (Natural), Menthol
Label structure9 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains sprains

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 (3.0%)

Menthol (2.6%)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Counterirritant

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

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

In case of accidental ingestion seek professional assistance or contact a poison control 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, dimethyl sulfone, glycerin, glycine soja (soybean) oil, eucalyptus globulus oil, piper nigrum (pepper) seed extract, centipedia cunninghamii extract, arctium majus root (burdock) extract, mentha piperita (peppermint) leaf extract, artemisia absinthium, uncaria tomentosa extract, zingiber officinale (ginger) root oil, arnica montana flower extract, zingiber officinale (ginger) root extract, d-ribose, sodium polycrylate, c18-21 alkane, trideceth-6, tocopherol, phenoxyethanol, iodopropynyl butylcarbamate

Questions or 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

Deep Pain Care Cold

New wt 1.1 oz. (31 mL)

Manufactured by SkinDeep for SkinFit Distributors

Savannah, GA 31405

Tel: 912-236-9430

www.mwlabs.com

Inflammation OTC Box
Inflammation OTC Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148408camphor 3 % / menthol 2.6 % Topical LotionPSN1
1148412Inflammation OTC Deep Pain Care (camphor 3 % / menthol 2.6 % ) Topical LotionPSN1
1148412camphor 30 MG/ML / menthol 26 MG/ML Topical Lotion [Inflammation OTC Deep Pain Care]SBD1
1148408camphor 30 MG/ML / menthol 26 MG/ML Topical LotionSCD1
1148408camphor 3 % / menthol 2.6 % Topical LotionSY1
1148412Inflammation OTC Deep Pain Care (camphor 3 % / menthol 2.6 % ) Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
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
45156-5610-22019-10-29C16284748780-1960f7f55-d65b-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45156-5610-1Inflammation OTCDeep Pain Care Cold31 g in 1 TUBELOTION311
45156-5610-2Inflammation OTCDeep Pain Care Cold1 in 1 BOXLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45156-5610INFLAMMATION OTC DEEP PAIN CARE COLD (CAMPHOR, MENTHOL) LOTION [SKIN DEEP]1Legacy NDC, 2 package rows20110901_234ad5c5-31bb-47e7-a29b-bcd079de2aeb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Camphor (Natural)ACTIVE INGREDIENTN20HL7Q9411
MentholACTIVE INGREDIENTL7T10EIP3A1
Camphor (Natural)ACTIVE MOIETYN20HL7Q9411
MentholACTIVE MOIETYL7T10EIP3A1
Alpha-TocopherolINACTIVE INGREDIENTH4N855PNZ11
Arctium Lappa RootINACTIVE INGREDIENT597E9BI3Z31
Arnica MontanaINACTIVE INGREDIENTO80TY208ZW1
Black Pepper OilINACTIVE INGREDIENTU17J84S19Z1
Cat's ClawINACTIVE INGREDIENT9060PRM18Q1
Dimethyl SulfoneINACTIVE INGREDIENT9H4PO4Z4FT1
GingerINACTIVE INGREDIENTC5529G5JPQ1
Ginger OilINACTIVE INGREDIENTSAS9Z1SVUK1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Iodopropynyl ButylcarbamateINACTIVE INGREDIENT603P14DHEB1
PeppermintINACTIVE INGREDIENTV95R5KMY2B1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Soybean OilINACTIVE INGREDIENT241ATL177A1
Trideceth-6INACTIVE INGREDIENT3T5PCR2H0C1
WaterINACTIVE INGREDIENT059QF0KO0R1
WormwoodINACTIVE INGREDIENTF84709P2XV1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45156-561045156-5610-1, 45156-5610-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
Camphor (Natural)N20HL7Q941ACTIB
MentholL7T10EIP3AACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Dimethyl Sulfone9H4PO4Z4FTIACT
Black Pepper OilU17J84S19ZIACT
Soybean Oil241ATL177AIACT
Arctium Lappa Root597E9BI3Z3IACT
PeppermintV95R5KMY2BIACT
WormwoodF84709P2XVIACT
Cat's Claw9060PRM18QIACT
Ginger OilSAS9Z1SVUKIACT
Arnica MontanaO80TY208ZWIACT
GingerC5529G5JPQIACT
Trideceth-63T5PCR2H0CIACT
Alpha-TocopherolH4N855PNZ1IACT
PhenoxyethanolHIE492ZZ3TIACT
Iodopropynyl Butylcarbamate603P14DHEBIACT

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 2 · 100 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Soybean OilSOYBEAN OIL241ATL177AINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Soybean OilSOYBEAN OIL241ATL177AINJECTION, EMULSION / INTRAVENOUS107100 mgExact identifier — unii candidate
7 equally ranked IID candidates
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
Soybean OilSOYBEAN OIL241ATL177AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GingerGINGERC5529G5JPQELIXIR / ORAL10 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Alpha-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 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
a1c737d4-eec3-4bda-b406-54aab5b66e3f234ad5c5-31bb-47e7-a29b-bcd079de2aeb2011-08-16WarningsExact identifier
spl id: a1c737d4-eec3-4bda-b406-54aab5b66e3f
spl set id: 234ad5c5-31bb-47e7-a29b-bcd079de2aeb

Reported adverse events (FAERS/openFDA)#

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