FDA.reportPublic FDA data

Vicks

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-07 01:02:40

Label at a glance#

ProductVicks VapoFreeze PAIN RELIEF
Active ingredientCAMPHOR (SYNTHETIC), LEVOMENTHOL
Label structure15 sections

Dosage and administration

adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily wash hands thoroughly with soap and water after each use children under 12 years of age: ask a doctor Store at no greater than 25°C (77°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3.6%

Menthol 16%

Active ingredients Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Topical analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple bachache
  • strains
  • sprains
  • bruises

provides penetrating pain relief

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or on irritated or damaged skin
  • with a heating pad

When using this product

OTC - WHEN USING SECTION

  • use only as directed. 
  • do not bandage tightly or use with medicated patch
  • avoid contact with eyes and mucous membranes
  • a transient burning sensation may occur upon application but generally disappears in several days
  • avoid applying into skin folds

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for mor than 7 days
  • symptoms clear up and occur again within a few days
  • redness is present or excessive skin irritation occurs
  • you experience severe burning pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older:

  • apply to the affected area not more than 3 to 4 times daily
  • wash hands thoroughly with soap and water after each use

children under 12 years of age:ask a doctor

Store at no greater than 25°C (77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., aminomethyl propanol, cetyl alcohol, cetyl palmintate, edetate disodium, fragrance, glycerin, isopropyl isostearate, PEG-100 stearate, polyoxyl 15 hydroxystearate, propylene glycol, steareth-2, stearic acid, stearyl alcohol, water

Questions?

OTC - QUESTIONS SECTION

1-855-446-4345

SPL UNCLASSIFIED SECTION

DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 2.5 OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS

Vapo

Freeze

PAIN RELIEVING LIQUID ROLL-ON

MAX STRENGTH MENTHOL‡ + CAMPHOR

PAIN RELIEF ROLL-ON

TARGETED • NO MESS

NET WT 2.5 OZ (70.9 g)

383383

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130030772213322GTIN-13: 0030772213322
EAN-13: 0030772213322
GTIN-12: 030772213322
UPC-A: 030772213322
GTIN storage (14 digits): 00030772213322		383.jpg
Data codeData Matrix21369266383.jpg

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-38384126-383-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
LEVOMENTHOLBZ1R15MTK7ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARYL ALCOHOL2KR89I4H1YIACT
STEARETH-2V56DFE46J5IACT
ALCOHOL3K9958V90MIACT
OCTADECYL DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATEV88J661G2PIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%)YY2HMJ9NZFIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CETYL ALCOHOL936JST6JCNIACT
CETYL PALMITATE5ZA2S6B08XIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ISOSTEARATEC67IXB9Y7TIACT
PEG-100 STEARATEYD01N1999RIACT
POLYOXYL 15 HYDROXYSTEARATE71YMM1X75OIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
TRIS(2,4-DI-TERT-BUTYLPHENYL)PHOSPHITE834E5H0LFFIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-05-22full-release2026-06-01 01:58:37

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
Vicks VapoFreeze PAIN RELIEFCAMPHOR, MENTHOLThe Procter & Gamble Manufacturing Company526cdb40-aa65-4885-e063-6294a90afa0c2026-05-22WarningsExact identifier
ndc (package): 84126-383-03
ndc (product): 84126-383
ndc11 (package): 84126038303
spl set id: 526cdb40-aa65-4885-e063-6294a90afa0c

Reported adverse events (FAERS/openFDA)#

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