MINTED LEAF COLD THERAPY RELIEF WITH CBD AND MENTHOL ROLL ON- menthol cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
MMG Consumer Brands, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis - simple backache - sprains - bruises and strains.
Authorization status:
OTC monograph not final
Authorization number:
73102-065-00

MINTED LEAF COLD THERAPY RELIEF WITH CBD AND MENTHOL ROLL ON-

menthol cream

MMG Consumer Brands, LLC

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.

----------

MINTED LEAF Cold Therapy Relief with CBD and Menthol Roll-On

Drug Facts

Active ingredient

Menthol 4.00%

Purpos e

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 Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arcticum Lappa (Burdock)

Root Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea)

Extract, Broad Spectrum Hemp Oil, Cetearyl Olivate, Cetyl Alcohol, Citric Acid,

Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Ilex

Paraguariensis (Yerba Mate’) Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa

Officinalis (Lemon Balm) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Sorbitan Olivate,

Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

Package Labeling:

MINTED LEAF COLD THERAPY RELIEF WITH CBD AND MENTHOL ROLL

ON

menthol cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7310 2-0 6 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

MMG Consumer Brands, LLC

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

40 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

WATER (UNII: 0 59 QF0 KO0 R)

ARCTIUM LAPPA RO O T (UNII: 59 7E9 BI3Z3)

ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)

INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

CANNABIS SATIVA WHO LE (UNII: B5ONF538 PB)

CETEARYL O LIVATE (UNII: 58 B6 9 Q8 4JO)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

ILEX PARAGUARIENSIS LEAF (UNII: 1Q9 53B4O4F)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

MELISSA O FFICINALIS (UNII: YF70 18 9 L0 N)

DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

SO RBITAN O LIVATE (UNII: MDL271E3GR)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

XANTHAN GUM (UNII: TTV12P4NEE)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:7310 2-0 6 5-

8 9 mL in 1 BOTTLE, WITH APPLICATOR; Type 0 : No t a

Co mbinatio n Pro duct

0 8 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 8 /0 1/20 19

Labeler -

MMG Consumer Brands, LLC (117036455)

Revised: 7/2019

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