Remedy Pain Relief Cream by RENU LABORATORIES, INC. REMEDY Pain Relief Cream

Remedy Pain Relief Cream by

Drug Labeling and Warnings

Remedy Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REMEDY PAIN RELIEF 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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REMEDY Pain Relief 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

JAR LABEL and BOX ART

BOX ART REMEDY

JAR SIDE LABEL

REMEDY PAIN RELIEF CREAM 
menthol 5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76348-630
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.6 g  in 112 g
Inactive Ingredients
Ingredient NameStrength
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)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
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)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CORN OIL (UNII: 8470G57WFM)  
SHEA BUTTER (UNII: K49155WL9Y)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
GUAIOL (UNII: I7WP008A91)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76348-630-051 in 1 BOX05/12/202108/15/2022
1NDC: 76348-630-04112 g in 1 JAR; 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(76348-630)

Revised: 8/2022