FDA.reportPublic FDA data

Dr. Teals Muscle Recovery Pain Gel 8%

Manufacturer
PDC Brands | Dhaliwal Laboratories, LLC
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:02:27

Label at a glance#

ProductDr. Teals
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

Uses: temporarily relieves minor pain associated with Simple backache arthritis muscle strains muscle sprains bruises

Dosage and administration

Adults and children over 12 years apply generously to affected area massage desired amount of Dr Teals Muscle Recovery Gel into affected area repeat as necessary, but no more than 4 times daily Children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active IngredientPurpose
Menthol 8%Topical Analgesic

Stop using and ask a doctor if

OTC - ASK DOCTOR SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is pesent
  • irritation develops

If pregnant or breast feeding, ask a health professional before use

DO NOT USE APPLY

OTC - DO NOT USE SECTION

do not apply to wouonds or damaged, broken or irritated skin

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use

OTC - QUESTIONS SECTION

Distributed By:
pdc brands

PDC BRANDS, Stamford, CT 06820

Made in USA

www.drteals.com

Questions? CALL (800)887-2738
NDC#61012-011-02

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice (Decolorized), Aminomethylpropanol, Arnica Montana Flower Extract, Camphor, Carbomer, Eucalyptus Globulus Leaf oil, Fragrance (Parfum), Glycerin, Isopropyl Alcohol, Isopropyl Myristae, Magnesium Sulfate (Epsom salt), Pinus Ponderosa Branch/ Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, SD Alcohol 40-B, Water (Aqua), Xanthan Gum

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY
when using this product
use only as directed
DO NOT BANDAGE TIGHTLY OR USE WITH HEATING PAD
avoid contact with eyes or mucous membranes
do not apply to wouonds or damaged, broken or irritated skin

USES

INDICATIONS & USAGE SECTION

Uses:
temporarily relieves minor pain associated with
Simple backache
arthritis
muscle strains
muscle sprains
bruises

DIRECTIONS

INSTRUCTIONS FOR USE SECTION

Adults and children over 12 years
apply generously to affected area
massage desired amount of Dr Teals Muscle Recovery Gel into affected area
repeat as necessary, but no more than 4 times daily
Children 12 years or younger:
ask a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

OTC - PURPOSE SECTION

Uses:

  • temporarily relieves minor pain associated with
  • Simple backache
  • arthritis
  • muscle strains
  • muscle sprains
  • bruises

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Box Art Work

Outer BoxOuter Box

Tube Art Work

Tube Art WorkTube Art Work

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283257menthol 8 % Topical GelPSN4
283257menthol 0.08 MG/MG Topical GelSCD4
283257menthol 8 % Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61012-011-012021-01-29C16284748780-1ba0f9c33-5459-a910-e053-dadaa90a0b85Dr. Teals Muscle Recovery Pain Gel 8%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61012-011-01Dr. Teals1 in 1 CARTONGEL14
61012-011-02Dr. Teals70.8 g in 1 TUBEGEL70.84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61012-011DR. TEALS (DR. TEALS MUSCLE RECOVERY PAIN RELIEVING GEL) GEL [PDC BRANDS]4Legacy NDC, 2 package rows20191230_6ac2ccdd-6e87-0fb1-e053-2991aa0a3b3b.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61012-01161012-011-02, 61012-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
MENTHOLL7T10EIP3AACTIB
EUCALYPTUS OIL2R04ONI662IACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)F68VH75CJCIACT
ISOPROPYL ALCOHOLND2M416302IACT
PINUS PINASTER SEED OILR3P3P606BYIACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MIACT
CAMPHOR OIL, WHITE26P3H26Z9XIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ROSEMARY OIL8LGU7VM393IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
9aa204e6-3437-ed12-e053-2995a90a51136ac2ccdd-6e87-0fb1-e053-2991aa0a3b3b2019-12-26WarningsExact identifier
spl id: 9aa204e6-3437-ed12-e053-2995a90a5113
spl set id: 6ac2ccdd-6e87-0fb1-e053-2991aa0a3b3b

Reported adverse events (FAERS/openFDA)#

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