FDA.reportPublic FDA data

Instant Antiseptic Pain Relief

Manufacturer
Chain Drug Market Association | Pharma Nobis, LLC
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:05:04

Label at a glance#

ProductInstant Antiseptic Pain Relief
Active ingredientCAMPHOR (NATURAL), PHENOL
Label structure11 sections

Indications and uses

Helps prevent infection and temporarily relieves pain and itching in minor burns, cuts, insect bites, scrapes, sunburn and other minor skin irritations.

Dosage and administration

Adult and children 2 yrs and older: apply to affected area 1 to 3 times daily. Children under 2 yrs of age: Consult a doctor before use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 10.8%, Phenol 4.7 %

Purpose

OTC - PURPOSE SECTION

Pain Reliever, Antiseptic

Uses:

INDICATIONS & USAGE SECTION

Helps prevent infection and temporarily relieves pain and itching in minor burns, cuts, insect bites, scrapes, sunburn and other minor skin irritations.

Warnings:

WARNINGS SECTION

For External Use Only. Do not induce vomiting. If vomiting occurs give fluids again. Do not use in or near the eyes: In case of eye contact, flush eyes with running water for 15 minutes, get medical attention immediately. Do not use on: deep punture wounds, animal bites, serious burns.

When using this product:

OTC - WHEN USING SECTION

Do not bandage. Do not use over large areas of the body.

Stop use and consult a doctor if:

OTC - STOP USE SECTION

Condition worsens. Symptoms last more than 7 days or clear up and occur again in a few days.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adult and children 2 yrs and older: apply to affected area 1 to 3 times daily.

Children under 2 yrs of age: Consult a doctor before use.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Citric acid, Eucalyptus Oil, Light Mineral Oil

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QCIAPR.jpgQCIAPR.jpgCaptureCapture

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308940camphor 10.8 % / phenol 4.7 % Topical SolutionPSN6
308940camphor 108 MG/ML / phenol 47 MG/ML Topical SolutionSCD6
308940camphor 10.8 % / phenol 4.7 % Topical SolutionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-060-45Instant Antiseptic Pain Relief45 mL in 1 BOTTLE, GLASSLIQUID456

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-060INSTANT ANTISEPTIC PAIN RELIEF (CAMPHOR 10.8% AND PHENOL 4.7%) LIQUID [CHAIN DRUG MARKET ASSOCIATION]6Current NDC, Legacy NDC, 1 package rows20231221_2cd60df3-bfde-4747-ba4f-7121612f2e63.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-060-45ML - Milliliter63868-06071eaf20f-c39b-4e28-ab87-e1fb354bb3c512014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9411
PHENOLACTIVE INGREDIENT339NCG44TV1
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9411
PHENOLACTIVE MOIETY339NCG44TV1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-06063868-060-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EUCALYPTUS OIL2R04ONI662IACT
LIGHT MINERAL OILN6K5787QVPIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
PHENOL339NCG44TVACTIB

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 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPEMULSION / TOPICAL68100 mgExact identifier — unii+route
16 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii+route
22 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPGEL / TOPICAL20 mgExact identifier — unii+route
16 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii+dosage form
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii+route
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCLOTH / TOPICAL4.2 mgExact identifier — unii+route
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLOIL / TOPICAL2 mgExact identifier — unii+route
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGEL / TOPICAL3 mgExact identifier — unii+route
22 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route
16 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii+dosage form
22 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM, AUGMENTED / TOPICAL25 %w/wExact identifier — unii+route
16 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / TOPICAL2509 mgExact identifier — unii+route
16 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route
16 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii+route
22 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / TOPICAL2509 mgExact identifier — unii+route
16 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPAEROSOL, FOAM / TOPICAL240 mgExact identifier — unii+route
16 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii+route
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii+route
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii+route
22 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPLOTION / TOPICAL48000 mgExact identifier — unii+route
16 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSHAMPOO / TOPICAL0.07 %w/wExact identifier — unii+route
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSHAMPOO / TOPICAL0.07 %w/wExact identifier — unii+route
22 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii+route
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii+route
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL / TOPICAL0.08 %w/wExact identifier — unii+route
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL / TOPICAL0.08 %w/wExact identifier — unii+route
22 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route
16 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii+route
22 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM, AUGMENTED / TOPICAL25 %w/wExact identifier — unii+route
16 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPAEROSOL, FOAM / TOPICAL240 mgExact identifier — unii+route
16 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPEMULSION / TOPICAL68100 mgExact identifier — unii+route
16 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPGEL / TOPICAL20 mgExact identifier — unii+route
16 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii+route
22 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPLOTION / TOPICAL48000 mgExact identifier — unii+route
16 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGEL / TOPICAL3 mgExact identifier — unii+route
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLOIL / TOPICAL2 mgExact identifier — unii+route
22 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route
16 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCLOTH / TOPICAL4.2 mgExact identifier — unii+route
22 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
Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Chain Drug Market Association2cd60df3-bfde-4747-ba4f-7121612f2e632023-12-20WarningsExact identifier
ndc (package): 63868-060-45
ndc (product): 63868-060
ndc11 (package): 63868006045
spl id: 0cf4b1c3-dc91-db2f-e063-6394a90ab347
spl set id: 2cd60df3-bfde-4747-ba4f-7121612f2e63

Reported adverse events (FAERS/openFDA)#

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