TRUE ESSENTIALS PAIN RELIEF ROLL ON- camphor, menthol, and methyl salicylate gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Camphor 4% Menthol 10% Methyl Salicylate 30%

Available from:

Fortune Hi-Tech Marketing, Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

.……..…….............….. Topical Analgesic ...……......……….....… Topical Analgesic .......….......… Topical Analgesic Temporarily relieves the minor aches and  pains of muscles and joints  associated with: - arthritis - strains - bruises - sprains - backache

Authorization status:

OTC monograph final

Summary of Product characteristics

TRUE ESSENTIALS PAIN RELIEF ROLL ON- CAMPHOR, MENTHOL, AND METHYL
SALICYLATE GEL
FORTUNE HI-TECH MARKETING, INC
_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._
----------
DRUG FACTS
ACTIVE INGREDIENTS
Camphor 4%
Menthol 10%
Methyl Salicylate 30%
PURPOS E
.……..…….............….. Topical Analgesic
...……......……….....… Topical Analgesic
.......….......… Topical Analgesic
US ES
Temporarily relieves the minor aches and pains of muscles and joints
associated with:
arthritis
strains
bruises
sprains
backache
WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT USE:
on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis like conditions
KEEP OUT OF REACH OF CHILDREN
In case of accidental ingestion, seek medical assistance or contact a
Poison Control Center immediately.
DIRECTIONS
■ Use only as directed
■ Adults and children 12 years of age and older apply
to affected area not more than 3 to 4 times daily
■ Children under 12 years of age ask a doctor
Water, Hydroxyethyl Cellulose, Edetate Disodium, Glyceryl Stearate Se,
Sorbitan Stearate, Stearic
Acid, Polysorbate 80, Potassium Hydroxide, Phenoxyethanol (and)
Caprylyl Glycol (and)
Ethylhexylglycerin (and) Hexylene Glycol
QUES TIONS ?
Call 1-859-422-7048
Placeholder Text
TRUE ESSENTIALS PAIN RELIEF ROLL ON
camphor, menthol, and methyl salicylate gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:2448 8 -0 24
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -
UNII:5TJD8 2A1ET)
CAMPHOR
(SYNTHETIC)
2.9 6 mL
in 74 mL
Fortune Hi-Tech Marketing, Inc
MENTHO L (UNII: L7T10 EIP3A) (Mentho l - UNII:L7T10 EIP3A)
Me ntho l
7.4 mL in 74 mL
METHYL SA LICYLA TE (UNII: LAV5U50 22Y) (Methyl Salicylate -
UNII:LAV5U50 22Y)
Methyl Sali