CLEAN REMEDIES CR PAIN RELIEF- menthol cream

CLEAN REMEDIES CR PAIN RELIEF by

Drug Labeling and Warnings

CLEAN REMEDIES CR PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Clean Remedies, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredient:

Menthol 2.00%

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Warnings:

For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

Do not apply

to wounds or damaged skin. Do not  bandage tightly. 

If pregnant or breast feeding,

contact physician prior to use.

Directions:

• Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
• Children under two-years of age: consult a physician.

Additional Information:

Store at room temperature.

Other Ingredients:

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bromelain, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cannabis Sativa (Full Spectrum) Hemp Extract, Carthamus Tinctorius (Safflower) Oil, Cetearyl Alcohol, Chondroitin Sulfate, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Oil, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Laureth-7, Melia Azadirachta (Neem) Oil, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM) Papain, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Salix Nigra (Willow) Bark Extract, SD-Alcohol 40B, Stearic Acid, Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Caramel Color.
*Denotes cerified organic ingredient.

Package Labeling:

INGREDIENTS AND APPEARANCE

CLEAN REMEDIES CR PAIN RELIEF 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73371-048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BROMELAINS (UNII: U182GP2CF3)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SAFFLOWER (UNII: 4VBL71TY4Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BERGAMOT OIL (UNII: 39W1PKE3JI)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
PEPPERMINT (UNII: V95R5KMY2B)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PAPAIN (UNII: A236A06Y32)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCOA (UNII: D9108TZ9KG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
CARAMEL (UNII: T9D99G2B1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73371-048-03	85 g in 1 TUBE; Type 0: Not a Combination Product	09/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/10/2019

Labeler - Clean Remedies, LLC (035818071)