MAXIMUM STRENGTH PAIN RELIEF SPORTS CREAM- sports cream cream 
Royal Labs Natural Cosmetics, 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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Sports Cream

Dosage & Administration

930mg CBD

Warnings

For external use only.

Do not use:

On wounds or damaged skin

mouth

genitals or any other mucous membrane

with a heating pad

if condition worsens

Inactive Ingredients

Butyrospermum Parkii Shea Butter, Cetearyl Glucoside, Cetearyl Alcohol, Glyceryl Stearate Citrate, CBD Hemp Extract, Aloe Barbadensis Leaf Juice, Tapioca Starch, Glycerin, Caprylic Capric Triglyceride, Xanthan Gum, Rosmarinus Officinalis Leaf Extract, Arnica Extract, Glyceryl Caprylate, Caprylhydroxamic Acid, Citric Acid

Indications & Usage

Directions: Adults and children 12 years of age and older: Rub onto affected area 3 to 4 times daily; Children under 12 years of age ask a doctor.

Keep out of reach of children

Purpose

For temporary relief of minor aches and pains of muscles associated with arthritis, muscle strain, bruises, sprains, backache

Active Ingredients

Menthol 10%

Methyl Salicylate 10%

Camphor Bark Oil 3%

Eucalyptus Leaf 2%

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MAXIMUM STRENGTH PAIN RELIEF SPORTS CREAM 
sports cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69580-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 mg  in 100 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3 mg  in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL2 mg  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ARNICA MONTANA (UNII: O80TY208ZW)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
HEMP (UNII: TD1MUT01Q7)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
ROSEMARY (UNII: IJ67X351P9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SHEA BUTTER (UNII: K49155WL9Y)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69580-100-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2018
2NDC:69580-100-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/03/201812/17/2021
Labeler - Royal Labs Natural Cosmetics, Inc. (197478480)
Registrant - Royal Labs Natural Cosmetics, Inc. (197478480)
Establishment
NameAddressID/FEIBusiness Operations
Royal Labs Natural Cosmetics, Inc.197478480manufacture(69580-100)

Revised: 12/2021
Document Id: d35de102-ab34-6130-e053-2995a90ab9c4
Set id: 701d0060-96b0-08cc-e053-2991aa0a2280
Version: 7
Effective Time: 20211217
 
Royal Labs Natural Cosmetics, Inc.