MAXIMUM STRENGTH PAIN CREAM WITH PURE HEMP EXTRACT- pain cream cream

Maximum Strength Pain Cream with Pure Hemp Extract by

Drug Labeling and Warnings

Maximum Strength Pain Cream with Pure Hemp Extract by is a Otc medication manufactured, distributed, or labeled by Royal Labs Natural Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage & Administration Section

930mg Hemp Extract (9.3mg per pump)

Warnings Section

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

Inactive Ingredients: Aqua, Butyrospermum Parkii (Shea) Butter, Cetearyl Glucoside, Cetearyl Alcohol, Glyceryl Stearate Citrate, Hemp Extract, Organic Aloe Barbadensis (Aloe Vera) Leaf Juice, Tapioca Starch Modified, Glycerin, Caprylic Capric Triglyceride, Xanthan Gum, Organic Rosmarinus Officinalis (Rosemary) Leaf Extract, Organic Arnica Extract, Glyceryl Caprylate, Caprylhydromamic 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

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

Purpose

Uses: For temporary relief of minor aches and pains of muscles and joints associated with: Arthritis, Muscle Strain, Bruises, Sprains, Backache

Active Ingredients

Menthol 10%

Methyl Salicylate 10%

Camphor Bark Oil 3%

Eucalyptus Leaf Oil 2%

Stono Creek Apothocary Maximum Strength Pain Cream with Pure Hemp Extract

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH PAIN CREAM WITH PURE HEMP EXTRACT 
pain cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69580-101
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ROSEMARY (UNII: IJ67X351P9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
XANTHAN GUM (UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
HEMP (UNII: TD1MUT01Q7)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
STARCH, TAPIOCA (UNII: 24SC3U704I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69580-101-34	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/25/2018

Labeler - Royal Labs Natural Cosmetics (197478480)

Registrant - Royal Labs Natural Cosmetics (197478480)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Labs Natural Cosmetics		197478480	manufacture(69580-101)