PAIN RELIEF CREAM TOPICAL ANALGESIC- menthol 6% cream

Pain Relief Cream by

Drug Labeling and Warnings

Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Cosmetic Specialty labs, Inc. (032973000)

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