Drug Facts

Active Ingredient

Menthol 6.0%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

arthritis
simple backache
muscle strains
sprains
bruises
cramps

Warnings

for external use only

When using this product

use only as directed
do not bandage tightly
avoid contact with eyes or mucous membranes
do not apply to wounds or damaged skin

Stop use and ask a doctor if

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

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 right away.

Directions

adults and children over 2 years:

apply generously to affected area
massage into painful area until thoroughly absorbed into skin
repeat as necessary, but no more than 4 times daily

children 2 years or younger: ask a doctor

Inactive ingredients

Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica montana, Butylene glycol, Calendula officinalis (Marigold), Capryl glycol, Calpsicum grutescens, Carbomer, Cantharius tinctorious (Safflower) Seed Oil, Centaureacyanus (Cornflower), Cetearyl alcohol, Cetyl alcohol, Chamomila recutita (Matricaria Chamomila), Coriandrum sativum (Coriander), Hamamelis virginiana (Witch Hazel), Bark/Leaf/Twig, Hypericum perforatum (St. John's Wort), Industrial Hemp geed oil, Methylsulfonylmethane, Phenoxyethanol, Purified water,Salix alba (Willow Bark), SD Alcohol40, Sorbitol, Tetrasodium EDTA, Tilla cordata (Lime Tree), Triethanolamine

Manufactured for: Good Energy Products

a DBA of Special Effort Ltd. Austin, TX 78701

www.goodenergyproducts.com (800) 698-ALOE

Made in the U.S.A.

PRINCIPAL DISPLAY PANEL

PDP Drtug facts

PAIN RELIEF CREAM TOPICAL ANALGESIC
menthol 6% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58133-222
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TRIETHANOLAMINE LAURYLAMINOPROPIONATE (UNII: 793J74ICPW)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPSICUM (UNII: 00UK7646FG)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CORIANDER OIL (UNII: 7626GC95E5)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SALIX ALBA BARK (UNII: 205MXS71H7)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SORBITOL (UNII: 506T60A25R)
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)
HEMP (UNII: TD1MUT01Q7)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
3-((3-CHLOROPHENYL)(4-(METHYLSULFONYL)PHENYL)METHYLENE)DIHYDRO-2(3H)-FURANONE, (3Z)- (UNII: 920350682Z)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58133-222-03	81 mL in 1 TUBE; Type 0: Not a Combination Product	10/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/31/2018

Labeler - Cosmetic Specialty labs, Inc. (032973000)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmetic Specialty labs, Inc.		032973000	manufacture(58133-222)

Dr. Wolfe's OTC Energized Pain Relief Cream