TOTAL MUSCLE RELIEF- menthol, camphor gel

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

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Active ingredient:
MENTHOL 3.9%, cAMPHOR 0.4%
Available from:
Nemadji Management LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
TOPICAL ANALGESIC TOPICAL RELIEF MUSCLE GEL
Authorization status:
OTC monograph not final
Authorization number:
73278-101-13

TOTAL MUSCLE RELIEF- menthol, camphor gel

Nemadji Management 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.

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ACTIVE INGREDIENTS

MENTHOL 3.9%

cAMPHOR 0.4%

PURPOSE

TOPICAL ANALGESIC

WARNINGS

EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN.

USES

TOPICAL RELIEF MUSCLE GEL

DIRECTIONS

FOR ADULTS AND CHILDREN 2 YEARS AND OLDER. ROLL GEL ONTO AFFECTED AREA,

REPEAT AS NEEDED. APPLICATIONS MAY BE REPEATED UP TO 4X DAILY OR AS

DIRECTED BY A CARE PROVIDER. FOR CHILDREN UNDER 2 YEARS OF AGE, CONSULT A

MEDICAL PROFESSIONAL.

INACTIVE INGREDIENTS

PURIFIED WATER, ISOPROPYL ALCOHOL, EXTRACT OF ALOE VERA, HEMP GLOWER OIL,

WITCH HAZEL AND SAGE, PROPYLENE GLYCOL, GLYCERIN, COCONUT OIL, SWEET

ALMOND OIL, DIMETHICONE COPOLYOL SILICA, CARBOMER, TRIETHANOLAMINE,

DMDM HYDANTOIN

TOTAL MUSCLE RELIEF

menthol, camphor gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:73278 -10 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

MENTHOL

3.9 g in 10 0 mL

CAMPHO R O IL (UNII: 75IZZ8 Y727) (CAMPHOR OIL - UNII:75IZZ8 Y727)

CAMPHOR OIL

0 .4 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

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

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

HEMP (UNII: TD1MUT0 1Q7)

WITCH HAZEL (UNII: 10 1I4J0 U34)

SAGE (UNII: 0 6 5C5D0 77J)

Nemadji Management LLC

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

GLYCERIN (UNII: PDC6 A3C0 OX)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

CARBO MER HO MO PO LYMER TYPE C ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 4Q9 3RCW27E)

ALMO ND O IL (UNII: 6 6 YXD4DKO9 )

PEG/PPG-18 /18 DIMETHICO NE (UNII: 9 H0 AO7T79 4)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:73278 -10 1-13

9 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /26 /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 2/16 /20 19

Labeler -

Nemadji Management LLC (100279564)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

DIVERSIFIED MANUFACTURING CORP

18 50 739 9 6

ma nufa c ture (73278 -10 1)

Revised: 8/2019

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