TRUE PAIN RELIEF PLUS- methyl salicylate, menthol, capsaicin lotion

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

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Active ingredient:
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)
Available from:
Nature City, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical analgesic Temporary relief of minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises ​Stop use and ask a doctor if • condition worsens • if symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops
Authorization status:
OTC monograph not final
Authorization number:
69180-001-08

TRUE PAIN RELIEF PLUS- methyl salicylate, menthol, capsaicin lotion

Nature City, 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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True Pain Relief Plus

ACTIVE INGREDIENTS:

Methyl Salicylate 10.00% w/w

Menthol 1.25% w/w

Capsaicin 0.025% w/w

PURPOSE

Topical analgesic

USES:

Temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple

backache strains sprains bruises

WARNINGS:

For external use only

When using this product use only as directed do not bandage tightly or use with a heating pad do

not apply to wounds or damaged skin

Avoid contact with eyes and mucous membranes

Stop use and ask a doctor if condition worsens if symptoms persist for more than 7 days or clear

up and occur again within a few days redness is present irritation develops

If pregnant or breast-feeding,

ask a health care provider before use.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison

Control Center right away.

DIRECTIONS:

Adults an children over 12 years:

apply generously to affected area massage into painful area

until thoroughly absorbed into skin repeat as necessary, but no more than 4 times daily wash hands

with soap and water after use

children under 12 years or younger:

consult a doctor

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Camphor, Caprylyl

Glycol, Cetyl Alcohol, Disodium EDTA, Isopropyl Myristate, Methylisothiazolinone, PEG-8,

Triethanolamine, Water

TRUE PAIN RELIEF PLUS

methyl salicylate, menthol, capsaicin lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 18 0 -0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

10 0 mg in 1 g

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

MENTHOL

12.5 mg in 1 g

CAPSAICIN (UNII: S0 7O44R1ZM) (CAPSAICIN - UNII:S0 7O44R1ZM)

CAPSAICIN

.25 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

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

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

Nature City, LLC

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET)

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 18 0 -0 0 1-

236 g in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/0 1/20 0 3

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 3/0 1/20 0 3

Labeler -

Nature City, LLC (026617122)

Revised: 4/2019

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