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

Dr. Teals by

Drug Labeling and Warnings

Dr. Teals by is a Otc medication manufactured, distributed, or labeled by PDC Brands, Dhaliwal Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

​Drug Facts

Active ingredients

Menthol 10%

Purpose

Topical Analgesic

Uses

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

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

​For external use only

Do not use

• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have

• redness over the affected area

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation occurs

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

• Use only as directed
• ​Adults and children 12 years of age and older:

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

• ​Children under 12 years of age: ​ask a doctor

Other information

• Store between 20° and 25°C (68° and 77°F)

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 Label2.jpg

INGREDIENTS AND APPEARANCE

DR. TEALS  PRE AND POST WORKOUT PAIN RELIEF
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61012-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61012-010-01	1 in 1 CARTON
1	NDC: 61012-010-57	57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/10/2015

Labeler - PDC Brands (037512746)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Laboratories, LLC		016754201	manufacture(61012-010)