FDA.reportPublic FDA data

op6 Menthol Cooling Pain Cream

Manufacturer
Renu Laboratories, Inc.
Effective date
2021-09-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:23

Label at a glance#

Productop6 Menthol Cooling Pain Cream
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

for temporary relief of minor aches and pains asssociated with arthritis simple backache muscle strains sprains bruises SIMPLE DATE CHANGE Nothing considered as major

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 5 percent

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

Topical Analgesic

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

INDICATIONS & USAGE SECTION

for temporary relief of minor aches and pains asssociated with

arthritis

simple backache

muscle strains

sprains

bruises

RECENT MAJOR CHANGES SECTION

SIMPLE DATE CHANGE

Nothing considered as major

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

631 697 0296

ACD HEALTH AND WELLNESS LLC

ACDHEALTH.COM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRODUCT LABEL AND BOX ART

COOLING CREAM BOX 2COOLING CREAM BOX 2

AK47 C CREAMAK47 C CREAM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-680-012025-01-30C16284748780-12cef2736-7a7b-d83d-e063-dadaa90ab31fop6 Menthol Cooling Pain Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-680-01op6 Menthol Cooling Pain Cream1 in 1 BOXCREAM11
76348-680-04op6 Menthol Cooling Pain Cream112 g in 1 JARCREAM1121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-680OP6 MENTHOL COOLING PAIN CREAM (MENTHOL) CREAM [RENU LABORATORIES, INC.]1Legacy NDC, 2 package rows20210915_cbab043c-9711-1d30-e053-2a95a90aefb0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-68076348-680-04, 76348-680-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
.BETA.-PINENE4MS8VHZ1HJIACT
HUMULENE54W56MD2WDIACT
TERPINOLENEN9830X5KSLIACT
LINALOOL, (+)-F4VNO44C09IACT
VALENCENE96H21P91IGIACT
MENTHOLL7T10EIP3AACTIB
CANNABIDIOL19GBJ60SN5IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 4500TVH7653921IACT
CORN OIL8470G57WFMIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
PEPPERMINT OILAV092KU4JHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
COCONUT OILQ9L0O73W7LIACT
WHITE WAX7G1J5DA97FIACT
SHEA BUTTERK49155WL9YIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
OLIVE OIL6UYK2W1W1EIACT
STEARIC ACID4ELV7Z65APIACT
GRAPEFRUIT OILYR377U58W9IACT
MAGNESIUM CHLORIDE02F3473H9OIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
LAURETH-7Z95S6G8201IACT
WITCH HAZEL101I4J0U34IACT
MYRCENE3M39CZS25BIACT
LIMONENE, (+)-GFD7C86Q1WIACT
CARYOPHYLLENEBHW853AU9HIACT
.ALPHA.-PINENEJPF3YI7O34IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cbab04af-2d76-5360-e053-2a95a90a245dcbab043c-9711-1d30-e053-2a95a90aefb02021-09-10WarningsExact identifier
spl id: cbab04af-2d76-5360-e053-2a95a90a245d
spl set id: cbab043c-9711-1d30-e053-2a95a90aefb0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.