SUGARLOAF ORGANICS MENTHOL REVIVE- menthol 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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SUGARLOAF MENTHOL REVIVE MENTHOL PAIN CREAM

Menthol 5%

Topical Analgesic

For temporary relief of minor aches and pains associated with

For external use only

Do not bandage tightly

Stop use and ask a doctor if

Keep out of reach of children.

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

Instructions: Massage into skin until thoroughtly absorbed. Repeat as needed. Store at room temperature.

Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil, with a proprietary blend of terpenes (alpha-bisabolol,

alpha-humulene, beta-caryophyllene, caryophyllene oxide, gualol, linalool),

Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Ethylhexylglycerin, Fragrance, Hemp-derived Cannabichromene (CBC), Cannabidiol (CBD), and Cannabigerol (CBG),

Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Sulfate, Mangifera Indica (Mango) Seed Buter,

Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Stearic Acid

Sugarloaf Organics

Drums, PA 18222

P: 570.866.5882

www.sugarloaforganic.com

Sugarloaf Organics Revive Menthol Pain Cream

Label and Box

Sugarloaf Boxsugarloaf label

SUGARLOAF ORGANICS MENTHOL REVIVE 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-996
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.9 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
CANNABIGEROL (UNII: J1K406072N)  
CANNABICHROMENE (UNII: K4497H250W)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PEG-100 STEARATE (UNII: YD01N1999R)  
WITCH HAZEL (UNII: 101I4J0U34)  
SHEA BUTTER (UNII: K49155WL9Y)  
LAURETH-7 (UNII: Z95S6G8201)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
WHITE WAX (UNII: 7G1J5DA97F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
COCONUT OIL (UNII: Q9L0O73W7L)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
CORN OIL (UNII: 8470G57WFM)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-996-011 in 1 BOX04/25/2023
1NDC:76348-996-04118 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/25/2023
Labeler - RENU LABORATORIES, INC. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
RENU LABORATORIES, INC.945739449manufacture(76348-996)

Revised: 4/2023
Document Id: fa2f9539-b704-a00b-e053-6394a90ae309
Set id: fa2f9539-b703-a00b-e053-6394a90ae309
Version: 1
Effective Time: 20230425
 
RENU LABORATORIES, INC.