THERA DERM ROLL ON- methyl salicylate liquid

Thera Derm Roll On by

Drug Labeling and Warnings

Thera Derm Roll On by is a Otc medication manufactured, distributed, or labeled by Manna Omni International Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

is to be used on sore muscles, for minor aches and pains. If pain persists for more than three days consult your doctor.Apply small amount onto affected area and repeat three (3) to four (4) times daily.

INDICATIONS & USAGE

For the relief of minor aches and pains, muscles aches or sprains, and minor back or arthritis pain.

Warning: For External Use Only

Use only as directed. Avoid contact with the eyes and mucous membranes. Do not apply to wounds, damaged or very sensitive skin. Test on a small area before use. DO not use in combination with other analgesic products.DO not bandage tightly or cover with any type of wrap except clothing. If condition worsens, or persists for more than seven days, discontinue use and consult a physician.

Keep out of the Reach of Children

If swallowed,get medical help or contact Poision Control right away.

Active Ingredients:

Menthol Natural

Methyl Salicilate

Peppermint oil

Menthol Crystal

Inactive Ingredients:

Aloe extract, Vitamin E Oil ,Lavender Flos,Angelicae Sinesis Rx, Cauda,Salviae,Miltiorrhiza, Chuanxiong, Paeoniae Rubra, Frakinsense, Mrryha, Carthami Flos, Persicae Sm, Cordalis Rz, Nototerygium, Incisum, and Angelica Pubescentis Rx.

PURPOSE

For the relief of minor aches and pains, related to strains and sprains and minor injury.

Theraderm Roll on

INGREDIENTS AND APPEARANCE

THERA DERM ROLL ON 
methyl salicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16903-171
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE 2-ETHYLBUTYRATE (UNII: J8D9175Q0G) (METHYL SALICYLATE 2-ETHYLBUTYRATE - UNII:J8D9175Q0G)	METHYL SALICYLATE 2-ETHYLBUTYRATE	18 mg  in 90 mg
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	4 mg  in 90 mg
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B)	PEPPERMINT OIL	9 mg  in 90 mg
MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)- (UNII: 2WL8FX4EEZ) (MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)- - UNII:2WL8FX4EEZ)	MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)-	9 mg  in 90 mg

Inactive Ingredients
Ingredient Name	Strength
PRUNUS PERSICA FLOWER BUD (UNII: 8S5Y7XFT0F)	2 mg  in 90 mg
NOTOPTERYGIUM FRANCHETII ROOT (UNII: KRT28P6ITK)	2 mg  in 90 mg
ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)	2 mg  in 90 mg
ZINGIBER CASSUMUNAR ROOT OIL (UNII: O47HX41O6C)	2 mg  in 90 mg
MYRRH (UNII: JC71GJ1F3L)	2 mg  in 90 mg
ALOE (UNII: V5VD430YW9)	2 mg  in 90 mg
SALVIA MILTIORRHIZA ROOT (UNII: 1693AM5SBN)	2 mg  in 90 mg
CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5)	2 mg  in 90 mg
LAVENDER OIL (UNII: ZBP1YXW0H8)	1 mg  in 90 mg
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)	2 mg  in 90 mg
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)	2 mg  in 90 mg
FRANKINCENSE OIL (UNII: 67ZYA5T02K)	2 mg  in 90 mg
STEARIC ACID (UNII: 4ELV7Z65AP)	5 mg  in 90 mg
PHENOXYETHANOL (UNII: HIE492ZZ3T)	1 mg  in 90 mg
COCONUT OIL (UNII: Q9L0O73W7L)	2 mg  in 90 mg

Product Characteristics
Color	white (Smooth Non -greasy Roll On)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16903-171-04	90 mg in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/31/2017

Labeler - Manna Omni International Incorporated (019109468)