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NDC 72268-0175-04 MIND BODY MATRIX PAIN RELIEF 15 mg/mL Details

MIND BODY MATRIX PAIN RELIEF 15 mg/mL

MIND BODY MATRIX PAIN RELIEF is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Functional Energetic, Inc.. The primary component is MENTHOL.

Product Information

NDC	72268-0175
Product ID	72268-175_6a46221b-c97c-abb9-e053-2991aa0ad3ea
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	MIND BODY MATRIX PAIN RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	15
Active Ingredient Units	mg/mL
Substance Name	MENTHOL
Labeler Name	Functional Energetic, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 72268-0175-04 (72268017504)

Pricing Information	N/A
NDC Package Code	72268-175-04
Billing NDC	72268017504
Package	1 TUBE in 1 BOX (72268-175-04) / 120 mL in 1 TUBE
Marketing Start Date	2018-04-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3667dd0d-942e-4101-ba98-cb013ae77cf5 Details

DRUG FACTS:

ACTIVE INGREDIENT:

MENTHOL 1.50%

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, BOSWELLIA SERRATA EXTRACT, CALENDULA 0FFICINALIS EXTRACT, CETEARYL OLIVATE, CETYL ALCOHOL, CHAMOMILLA RECUTITA (CHAMOMILE) EXTRACT, CITRUS LIMONUM MEDICA (LEMON BALM) EXTRACT, G-AMINOBUTYRIC ACID, GLUCONOLACTONE, GLYCERIN, GLYCERYL STEARATE, HELIANTHUS

ANNUUS (SUNFLOWER) OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, LECITHIN, MELALEUCA ALTERNIFOLIA (TEA TREE) OIL, MENTHA

PIPERITA (PEPPERMINT) OIL, METHYL SALICYLATE (WINTERGREEN) OIL, METHYLSULFONYLMETHANE (MSM), SILICA, SODIUM BENZOATE, SORBITAN OLIVATE, TAPIOCA STARCH, L-THEANINE, XANTHAN GUM, ZEMEA (CORN) PROPANEDIOL.

Package Labeling:

INGREDIENTS AND APPEARANCE

MIND BODY MATRIX PAIN RELIEF

menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72268-175
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHAMOMILE (UNII: FGL3685T2X)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYL SALICYLATE (UNII: LAV5U5022Y)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STARCH, TAPIOCA (UNII: 24SC3U704I)
THEANINE (UNII: 8021PR16QO)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72268-175-01	1 in 1 BOX	04/20/2018
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:72268-175-04	1 in 1 BOX	04/20/2018
2		120 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC:72268-175-10	1 in 1 CARTON	04/20/2018
3		3840 mL in 1 JUG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/20/2018

Labeler - Functional Energetic, Inc. (080459677)

Revised: 4/2018

Document Id: 6a46221b-c97c-abb9-e053-2991aa0ad3ea

Set id: 3667dd0d-942e-4101-ba98-cb013ae77cf5

Version: 2

Effective Time: 20180420