FROM EARTH PENETRATING MENTHOL PAIN RELIEF ROLL ON

FROM EARTH PENETRATING MENTHOL PAIN RELIEF ROLL ON by

Drug Labeling and Warnings

FROM EARTH PENETRATING MENTHOL PAIN RELIEF ROLL ON by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FROM EARTH PENETRATING MENTHOL PAIN RELIEF ROLL ON- menthol roll-on liquid 
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.

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FROM EARTH PENETRATING MENTHOL PAIN RELIEF ROLL ON

Active Ingredient

Menthol 5 percent

Purpose

Topical Analgesic

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

  • bruises
  • sprains
  • arthritis
  • strains

For external use only

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.

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

Keep out of reach of children

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

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 Ingredients:

Arnica Montana (Arnica) Extract, Cannabidiol (CBD) Hemp-derived, Cannabigerol (CBG) Hemp-derived, Cannabis Sativa (Hemp) Seed Oil with a proprietary mix of terpenes (alpha-bisabolol, alpha-humulene, alpha-pinene, alpha-terpinene, beta-caryophyllene, beta-myrcene, beta-pinene, caryophyllene oxide, cis-beta-ocimene, D-limonene, eucalyptol, gamma-terpinene, guaiol, linalool, menthol, p-cymene, terpinolene, trans-nerolidol), Deionized Water, Fragrance, Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate.

Questions? Comments?

contact us at

844 44-FE-CBD

PACKAGE LABEL From Earth Roll On Label

AND BOX ART

BOX ART

FROM EARTH PENETRATING MENTHOL PAIN RELIEF ROLL ON 
menthol roll-on liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76348-620
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.2 g  in 84 g
Inactive Ingredients
Ingredient NameStrength
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
GUAIOL (UNII: I7WP008A91)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WITCH HAZEL (UNII: 101I4J0U34)  
EUCALYPTOL (UNII: RV6J6604TK)  
.GAMMA.-TERPINENE (UNII: 4YGF4PQP49)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-TERPINENE (UNII: I24X278AP1)  
CARYOPHYLLENE (UNII: BHW853AU9H)  
.BETA.-CARYOPHYLLENE OXIDE (UNII: S2XU9K448U)  
.BETA.-OCIMENE, (3Z)- (UNII: 472UVP4R7T)  
.BETA.-PINENE (UNII: 4MS8VHZ1HJ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
CANNABIGEROL (UNII: J1K406072N)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
HUMULENE (UNII: 54W56MD2WD)  
.ALPHA.-PINENE (UNII: JPF3YI7O34)  
ARNICA MONTANA (UNII: O80TY208ZW)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MYRCENE (UNII: 3M39CZS25B)  
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
P-CYMENE (UNII: 1G1C8T1N7Q)  
TERPINOLENE (UNII: N9830X5KSL)  
NEROLIDOL (UNII: QR6IP857S6)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76348-620-011 in 1 BOX05/12/202108/15/2022
1NDC: 76348-620-0384 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/12/202108/15/2022
Labeler - RENU LABORATORIES, INC. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
RENU LABORATORIES, INC.945739449manufacture(76348-620)

Revised: 8/2022