OP6 MENTHOL WARMING PAIN CREAM- menthol cream

op6 Menthol Warming Pain Cream by

Drug Labeling and Warnings

op6 Menthol Warming Pain Cream by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 5 percent

Warnings

For external use only

When using this product do not bandage tightly

avoid contact with eye

do not apply to wounds or damaged skin

Stop use and ask doctor

if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

If swallowed get medical help or contact Poison Control Center right away

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

PURPOSE

Topical Analgesic

DOSAGE & ADMINISTRATION

Directions

adults and children 12 years of age and older

apply generously to affected area

massage into painful area until thoroughly absorbed into skin

repeat as necessary

INACTIVE INGREDIENT

Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract and proprietary terpene blend (Myrcene, b-Caryophyllene, d-Limonene, Humulene, Terpinolene, a-Pinene, Linalool, b-Pinene, Valencene, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Glyceryl Stearate, Grapefruit Oil, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus (Vegetable) Oil, PEG-100, Phenoxyethanol, Polyacrylamide, Stearic Acid

Uses

for temporary relief of minor aches and pains asssociated with

arthritis

simple backache

muscle strains

sprains

bruises

QUESTIONS OR COMMENTS

631 697 0296

ACD HEALTH AND WELLNESS LLC

ACDHEALTH.COM

PRINCIPAL DISPLAY PANEL

PRODUCT LABEL AND BOX ART

INGREDIENTS AND APPEARANCE

OP6 MENTHOL WARMING PAIN CREAM 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-681
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.6 g  in 112 g

Inactive Ingredients
Ingredient Name	Strength
TABASCO PEPPER (UNII: J1M3NA843L)
.BETA.-PINENE (UNII: 4MS8VHZ1HJ)
HUMULENE (UNII: 54W56MD2WD)
TERPINOLENE (UNII: N9830X5KSL)
LINALOOL, (+)- (UNII: F4VNO44C09)
VALENCENE (UNII: 96H21P91IG)
CANNABIDIOL (UNII: 19GBJ60SN5)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)
CORN OIL (UNII: 8470G57WFM)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
COCONUT OIL (UNII: Q9L0O73W7L)
WHITE WAX (UNII: 7G1J5DA97F)
SHEA BUTTER (UNII: K49155WL9Y)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
OLIVE OIL (UNII: 6UYK2W1W1E)
STEARIC ACID (UNII: 4ELV7Z65AP)
GRAPEFRUIT OIL (UNII: YR377U58W9)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
LAURETH-7 (UNII: Z95S6G8201)
WITCH HAZEL (UNII: 101I4J0U34)
MYRCENE (UNII: 3M39CZS25B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CARYOPHYLLENE (UNII: BHW853AU9H)
.ALPHA.-PINENE (UNII: JPF3YI7O34)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-681-01	1 in 1 BOX	09/14/2021
1	NDC: 76348-681-04	112 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	09/14/2021

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-681)