CBD PAIN RELIEF CREAM- lidocaine hydrochloride, menthol cream

CBD PAIN RELIEF Cream by

Drug Labeling and Warnings

CBD PAIN RELIEF Cream 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

Uses

temporarily relives minor pain, itching and irritation due to/associated with:  arthritis simple backaches muscle strain  sprains bruises minor cuts/scrapes  insect bites.

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 to increase.

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

Directions

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

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 (aloe) leaf juice*, cannabis sativa (hemp) extract, 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

1-800-279-7282 or www.triderma.com

SPL UNCLASSIFIED SECTION

THC FREE

Triple InfusedTM with clinically proven ingredients, essential botanicals and cannabinoid-rich, hemp-derived CBD.

Long-lasting  Fast-acting  Non-greasy

Light menthol scent disappears quickly

Distributed by:
Genuine Virgin Aloe Corp.
Corona, CA 92879

Packaging

INGREDIENTS AND APPEARANCE

CBD PAIN RELIEF CREAM 
lidocaine hydrochloride, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-207
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)
CANNABIS SATIVA SEED (UNII: QE567Z26NG)
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 TYPE I (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: 10738-207-20	1 in 1 CARTON	12/30/2019
1	NDC: 10738-207-21	57 g in 1 JAR; 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	12/30/2019

Labeler - Genuine Virgin Aloe Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-207)