FDA.reportPublic FDA data

ValleGel Prep Topical Analgesic Gel

Manufacturer
Plum Valley Pharma LLC
Effective date
2021-09-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:34:42

Label at a glance#

ProductValleGel Prep
Active ingredientMETHYL SALICYLATE, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

Temporarily relieves minor pain associated with: Arthritis Simple Backache Muscle Strains Bruises Muscle Sprains

Dosage and administration

Apply on affected area, not more than 3 to 4 times daily Children under 12 years of age; consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with:

  • Arthritis
  • Simple Backache
  • Muscle Strains
  • Bruises
  • Muscle Sprains

Warnings

WARNINGS SECTION

For External use only

When using this product

  • avoid contact with eyes and mucous membranes
  • do no apply to wounds or damaged skin
  • do not bandage tightly or use with a heating pad
  • use only as directed

Stop use and ask a doctor if condition worsens; symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help right away. If pregnant Or Breast-Feeding, Ask A Health Professional Before Use

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply on affected area, not more than 3 to 4 times daily
  • Children under 12 years of age; consult a doctor

Other Information

OTHER SAFETY INFORMATION

  • Store at 20-25ºC (68-77ºF) Store away from heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl alcohol, Carbomer, Pemulen, Polysorbate 80, Purified Water, Triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Questions or comments? Call 1-866-248-1553

ValleGel Prep Topical Analgesic Gel

NDC 82226-030-57

Qty 2oz (56.7G)

labellabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82226-030-57EA - Each82226-030acc8f687-2e63-4b5f-bd41-2bd650cc012c12021-12-08

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82226-03082226-030-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
CARBOMER 9404Q93RCW27EIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
METHYL SALICYLATELAV5U5022YACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

Source Document#

Source XML

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
7ebc937b-1f6f-4b27-87be-c9cffff119aacd13ed14-160b-8935-e053-2995a90aa1392022-07-04WarningsExact identifier
spl set id: cd13ed14-160b-8935-e053-2995a90aa139

Reported adverse events (FAERS/openFDA)#

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