DR. TEALS PRE AND POST WORKOUT PAIN RELIEF- menthol cream 
PDC Brands

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dr. Teal's Pre and Post Workout Pain Relief Cream

​Drug Facts

Active ingredients

Menthol 10%

Purpose

Topical Analgesic

Uses

Temporarily relieves the minor aches and pains of muscles and joints associated with:

Warnings

​For external use only

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

Apply a thin layer to affected area not more than 3 to 4 times daily, allowing minimum of 2-3 hours in between applications.

Other information

Inactive ingredients:

Cetearath 20, Cetyl Alcohol, Cetyl Ester, Ethylhexylglycerin, Fragrance(Parfum), Glycerin, Glyceryl Stearate SE, Isopropyl Palmitate, Magnesium Sulfate (Epsom Salt), Phenoxyethanol, Polyquaternium 37, PPG-1 Trideceth-6, Propylene Glycol Dicaprylate/Dicaprate, Simethicone, Stearic Acid, Stearyl Alcohol, Triethanolamine, Water (Aqua).

Principal Display Panel
Dr. Teal's Pre & Post Workout Pain Relief Cream
2 oz./57g
NDC: 61012-010-57

Label1.jpg Label1 Label2.jpg Label2

DR. TEALS  PRE AND POST WORKOUT PAIN RELIEF
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61012-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ESTERS WAX (UNII: D072FFP9GU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYQUATERNIUM 37 (200 MPA.S) (UNII: 67C1D6YV24)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61012-010-011 in 1 CARTON
1NDC:61012-010-5757 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/10/2015
Labeler - PDC Brands (037512746)
Establishment
NameAddressID/FEIBusiness Operations
Dhaliwal Laboratories, LLC016754201manufacture(61012-010)

Revised: 12/2015
Document Id: 2801a538-d18f-328e-e054-00144ff88e88
Set id: 4346db64-6433-4815-aaa2-623a15d7920a
Version: 4
Effective Time: 20151228
 
PDC Brands