TRIDERMA PAIN RELIEF- lidocaine hcl, menthol cream

TRIDERMA PAIN RELIEF by

Drug Labeling and Warnings

TRIDERMA PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Genuine Virgin Aloe Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Active ingredients 

Lidocaine HCl 4.0%

Menthol 1.0%

Purpose

Topical Analgesic/Anesthetic

INDICATIONS & USAGE

Uses temporarily relieves minor pain, itching and irritation due to/associated with: arthritis simple backaches muscle strain sprains bruises minor cuts/scrapes 

WARNINGS

Warnings For external use only.

Ask a doctor before use if you have a heart condition.

Do not use if you are allergic to any other type of numbing medicine in large quantities, particularly over raw surfaces or blistered areas on infections on deep puncture wounds if pregnant or breastfeeding.

When using this product do not use over large skin areas do not apply heat, bandages or plastic wrap to treated areas do not use in or near the eyes wash hands immediately after using.

Stop use and ask a doctor if allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase.

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

DOSAGE & ADMINISTRATION

Directions apply generously up to 3 to 4 times daily. For use on adults and children 12 years and older. Children under 12 - ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients: water, caprylic/capric triglyceride, isopropyl palmitate, propanediol, glycerin, stearyl alcohol, butyrospermum parkii (shea) butter, acrylates/c10-30 alkyl acrylate crosspolymer, behenyl alcohol, tetrahydroxypropyl ethylenediamine, glyceryl stearate, peg-100 stearate, allantoin, cetearyl alcohol, ceteareth-20, persea gratissima (avocado) oil, calophyllum inophyllum (tamanu) seed oil, polysorbate 60, aloe barbadensis leaf juice*, arnica montana flower extract, chamomilla recutita (matricaria) flower extract, hypericum perforatum (st. john's wort) flower/leaf/stem extract, boswellia serrata gum, sodium polyacrylate, hydrogenated polydecene, trideceth-6, phenoxyethanol, ethylhexylglycerin.*Certified Organic Ingredient - Mayacert Certifier

QUESTIONS

Questions? 1-800-279-7282 M-F 8am-4pm PST

SPL UNCLASSIFIED SECTION

No Burning · Non-Greasy

Temporarily relieves minor aches & pains of muscles & joints from arthritis, simple backaches, strains, sprains & bruises

AP4 BOTANICAL

ALOE VERA COMPLEX

With Lidocaine HCl & Menthol

This specialized formula combines two proven maximum strength pain relievers, Lidocaine HCl and Menthol for minor relief of all types of aches and pains. It’s ideal for Arthritis, simple backaches, muscle strains, bruises, minor cuts, scrapes, skin irritations and even insect bites.

Contains No Cortisone or Parabens

visit www.triderma.com

Dist. by: Genuine Virgin Aloe Corp., Corona, CA 92879 
Made in USA 

Pain Relief Cream is a unique formula that helps provide long-lasting comfort and fast pain relief.

It combines the best of nature’s healing botanicals and science to help relieve pain, so that you can get on with your day.

· AP4® Aloe Vera Complex is a proprietary botanical blend made with Certified Organic Aloe Vera*.

· St. John’s Wort, Arnica & Boswellia

· Contains a touch of Menthol for extra pain relief - light scent, disappears quickly.

Packaging

Packaging

INGREDIENTS AND APPEARANCE

TRIDERMA PAIN RELIEF 
lidocaine hcl, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SHEA BUTTER (UNII: K49155WL9Y)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DOCOSANOL (UNII: 9G1OE216XY)
EDETOL (UNII: Q4R969U9FR)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ALLANTOIN (UNII: 344S277G0Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
AVOCADO OIL (UNII: 6VNO72PFC1)
TAMANU OIL (UNII: JT3LVK84A1)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CHAMOMILE (UNII: FGL3685T2X)
ST. JOHN'S WORT (UNII: UFH8805FKA)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10738-073-20	1 in 1 CARTON	08/30/2019
1	NDC: 10738-073-21	57 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 10738-073-41	113 g in 1 JAR; Type 0: Not a Combination Product	08/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/30/2019

Labeler - Genuine Virgin Aloe Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-073)