MAXIMUM STRENGTH PAIN RELIEF SPORTS CREAM- sports cream cream

Maximum Strength Pain Relief Sports Cream by

Drug Labeling and Warnings

Maximum Strength Pain Relief Sports Cream by is a Otc medication manufactured, distributed, or labeled by Royal Labs Natural Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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%

Image

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH PAIN RELIEF SPORTS CREAM 
sports cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69580-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 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 OIL	2 mg  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69580-100-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2018
2	NDC: 69580-100-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2018
3	NDC: 69580-100-20	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2018
4	NDC: 69580-100-30	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2018
5	NDC: 69580-100-40	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2018
6	NDC: 69580-100-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/03/2018

Labeler - Royal Labs Natural Cosmetics, Inc. (197478480)

Registrant - Royal Labs Natural Cosmetics, Inc. (197478480)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Labs Natural Cosmetics, Inc.		197478480	manufacture(69580-100)