OP6 MENTHOL COOLING PAIN CREAM- menthol cream 
Renu Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

op6 Menthol Cooling Pain Cream

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.

Topical Analgesic

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

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

PRODUCT LABEL AND BOX ART

COOLING CREAM BOX 2

AK47 C CREAM

OP6 MENTHOL COOLING PAIN CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-680
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.6 g  in 112 g
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-680-011 in 1 BOX09/10/2021
1NDC:76348-680-04112 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/10/2021
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-680)

Revised: 9/2021
Document Id: cbab04af-2d76-5360-e053-2a95a90a245d
Set id: cbab043c-9711-1d30-e053-2a95a90aefb0
Version: 1
Effective Time: 20210910
 
Renu Laboratories, Inc.