FDA.reportPublic FDA data

AK4 7 Menthol Warming Pain Relief Cream

Manufacturer
RENU LABORATORIES, INC.
Effective date
2020-08-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:23:39

Label at a glance#

ProductAK47 MENTHOL WARMING
Active ingredientMENTHOL
Label structure11 sections

Dosage and administration

adults and children 12 years of age and older apply generously to affected area massage into painful area until thoroughy absorbed into skin repeat as necessary.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol

5%

OTC - STOP USE SECTION

Stop use and ask a doctor if: condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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

OTC - QUESTIONS SECTION

Questions or Comments

info@ak47painrelief.com

OTC - WHEN USING SECTION

When using this product: Do not bandage tightly

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use heating pads or other heating devices.

WARNINGS SECTION

For external use only

INDICATIONS & USAGE SECTION

Uses: for temporary relief of minor aches and pains associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older

  • apply generously to affected area
  • massage into painful area until thoroughy absorbed into skin
  • repeat as necessary.

INACTIVE INGREDIENT SECTION

Butyrospermum Parkii (Shea Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Fragrance, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Olus Oil (vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Stearic Acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COOLING CREAM LABEL

COOLING CREAM LABELCOOLING CREAM LABEL

COOLING CREAM BOX

COOLING CREAM BOXCOOLING CREAM BOX

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
76348-521-012022-01-28C16284748780-1d6a99b39-43f3-a426-e053-dadaa90af4c2AK4 7 Menthol Warming Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-521-01AK47 MENTHOL WARMING1 in 1 BOXCREAM13
76348-521-04AK47 MENTHOL WARMING112 g in 1 JARCREAM1123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-521AK47 MENTHOL WARMING (MENTHOL WARMING) CREAM [RENU LABORATORIES, INC.]3Legacy NDC, 2 package rows20200804_abfb3b65-2fc2-9604-e053-2a95a90a2ce0.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-52176348-521-04, 76348-521-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
LINALOOL, (+)-F4VNO44C09IACT
MENTHOLL7T10EIP3AACTIB
CARYOPHYLLENEBHW853AU9HIACT
PINENE996299PUKBIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
MAGNESIUM CHLORIDE02F3473H9OIACT
CANNABIDIOL19GBJ60SN5IACT
LIMONENE, (+)-GFD7C86Q1WIACT
STEARIC ACID4ELV7Z65APIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
COCONUT OILQ9L0O73W7LIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
WITCH HAZEL101I4J0U34IACT
CORN OIL8470G57WFMIACT
MYRCENE3M39CZS25BIACT
TERPINEOLR53Q4ZWC99IACT
PEG-100 STEARATEYD01N1999RIACT
WHITE WAX7G1J5DA97FIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
SHEA BUTTERK49155WL9YIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
OLIVE OIL6UYK2W1W1EIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
TABASCO PEPPERJ1M3NA843LIACT

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
abfb3a46-7fe4-915d-e053-2a95a90aeec2abfb3b65-2fc2-9604-e053-2a95a90a2ce02020-08-03WarningsExact identifier
spl id: abfb3a46-7fe4-915d-e053-2a95a90aeec2
spl set id: abfb3b65-2fc2-9604-e053-2a95a90a2ce0

Reported adverse events (FAERS/openFDA)#

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