AK47 Cooling Roll-On

Manufacturer
Renu Laboratories, Inc.
Effective date
2020-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:29

Label at a glance#

ProductAK47 Cooling Roll-On
Active ingredientMENTHOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient: Menthol 1.25%

OTC - PURPOSE SECTION

Purpose Topical Analgesic

INDICATIONS & USAGE SECTION

Uses

for temporary relief of minor aches and pains of muscles and joints associated with

  • bruises
  • sprains
  • arthritis
  • strains

WARNINGS SECTION

Warnings

For external use only.

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 with heating pads or other heating devices.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 12 years of age and older, apply to affected area no more than 10 times a day as needed for pain.
  • children under 12 years of age: do not use, consult a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Deionized Water, Fragrance, Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Virginiana Hamamelis (Witch Hazel).

OTC - QUESTIONS SECTION

Questions? Comments?

info@CBDdispensaryshop.com

STATEMENT OF IDENTITY SECTION

AK4 7 TM

Cooling Roll-On

Pain Relief

RECENT MAJOR CHANGES SECTION

USES CHANGED TO VARIOUS BULLET POINTS

5/2020

DOSAGE AND ADMINISTRATION

Changes made to Directions

5/2020

LABEL AND BOX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AK47 LABEL AND PRODUCT BOX

AK47 boxAK47 box

label AK47label AK47

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
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
76348-570-012022-01-28C16284748780-1d6a99b39-cf94-a426-e053-dadaa90af4c2AK4 7 Cooling Roll-On Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-570-01AK47 Cooling Roll-On1 in 1 BOXLIQUID11
76348-570-03AK47 Cooling Roll-On84 g in 1 APPLICATORLIQUID841

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-570AK47 COOLING ROLL-ON (MENTHOL ROLL-ON) LIQUID [RENU LABORATORIES, INC.]1Legacy NDC, 2 package rows20200812_ac9ba695-afa3-118f-e053-2a95a90a8168.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-57076348-570-03, 76348-570-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
ac366e60-24a5-0fd3-e053-2a95a90adde8ac9ba695-afa3-118f-e053-2a95a90a81682020-08-06WarningsExact identifier
spl id: ac366e60-24a5-0fd3-e053-2a95a90adde8
spl set id: ac9ba695-afa3-118f-e053-2a95a90a8168

Reported adverse events (FAERS/openFDA)#

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