FROM EARTH Therapeutic Menthol Cream

FROM EARTH Therapeutic Menthol Cream by

Drug Labeling and Warnings

FROM EARTH Therapeutic Menthol Cream by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FROM EARTH THERAPEUTIC MENTHOL CREAM- menthol 5% 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.

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FROM EARTH Therapeutic Menthol Cream

Menthol 5 percent

Topical Analgesic

Uses

for temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

Warnings

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 Contro Center right away.

Questions? Comments?

contact us at

remedycbdcbg.com

Inactive Ingredients

Butyrospermum Parkii (Shea) Butter, 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),

Directions

adults and children 12 years of age and older

• apply liberally to affected area
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary

FROM EARTH JAR LABEL AND BOX ART

FROM EARTH THERAPEUTIC MENTHOL CREAM 
menthol 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-625
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.6 g  in 112 g

Inactive Ingredients
Ingredient Name	Strength
P-CYMENE (UNII: 1G1C8T1N7Q)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
.GAMMA.-TERPINENE (UNII: 4YGF4PQP49)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARYOPHYLLENE (UNII: BHW853AU9H)
.BETA.-PINENE (UNII: 4MS8VHZ1HJ)
HUMULENE (UNII: 54W56MD2WD)
.ALPHA.-PINENE (UNII: JPF3YI7O34)
.ALPHA.-TERPINENE (UNII: I24X278AP1)
CANNABIDIOL (UNII: 19GBJ60SN5)
CANNABIGEROL (UNII: J1K406072N)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
PEPPERMINT OIL (UNII: AV092KU4JH)
PEG-100 STEARATE (UNII: YD01N1999R)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
NIACINAMIDE (UNII: 25X51I8RD4)
CORN OIL (UNII: 8470G57WFM)
SHEA BUTTER (UNII: K49155WL9Y)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
GUAIOL (UNII: I7WP008A91)
EUCALYPTOL (UNII: RV6J6604TK)
MYRCENE (UNII: 3M39CZS25B)
.BETA.-CARYOPHYLLENE OXIDE (UNII: S2XU9K448U)
.BETA.-OCIMENE, (3Z)- (UNII: 472UVP4R7T)
TERPINOLENE (UNII: N9830X5KSL)
NEROLIDOL (UNII: QR6IP857S6)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
WHITE WAX (UNII: 7G1J5DA97F)
LAURETH-7 (UNII: Z95S6G8201)
OLIVE OIL (UNII: 6UYK2W1W1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-625-01	1 in 1 BOX	05/12/2021	08/15/2022
1	NDC: 76348-625-04	112 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/12/2021	08/15/2022

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-625)

Revised: 8/2022

Document Id: e78d0ef3-c89c-6158-e053-2995a90afab3

34390-5

Set id: c24b7801-2ea2-1b44-e053-2995a90a89c9

Version: 2

Effective Time: 20220831