THERADERM- methyl salicylate 2-ethylbutyrate spray

TheraDerm by

Drug Labeling and Warnings

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

Drug Details [pdf]

Warning: For External Use Only.

Use only as directed. Avoid contact with eyes or mucus menmbranes. Do not apply to worn, damaged, or very sensitive skin. Test on a small area before use. Do not Use in combination with other external analgesic products. Do not bandage tightly, or cover with any type of wrap, except clothing. If condition worsens , or persists for more than 7 days, discontinue use and consult a physcian.

Keep out of the reach of Children.

If swallowed, get medical attention or contact poision control Immediately.

INDICATIONS & USAGE

DIrections: Spray a small amount onto affected area. Repeat 3-4 times daily.

Dosage:

Spray small amount onto affected area every 6 hours no more than 4 times a day.

Other Ingredients:

Aloe Extract, am pelopsis radix extract, bletilla tuber extract, Carthmiflos extract,cimicifugae rhizome extract,echinopsis radix extract, glycerin, glycerrhizae radix extract,kaolin,methyl saliciate, myrrha extract, frankincense extract,Poly Acrylic acid,polysorbate 80,polyvinyl alcohol,propyl glycol,propyl paraben, purified water,rhei rhizome extract,titanium oxide,triethanolamine,glucosamine,and MSM.

Active Ingredients:

Methyl Salcylate, Menthol Natural (From Peppermint oil), and Menthol Crystal Solution.

Purpose:

For the temporary relief of minor arthritis pain, simple back ache, muscle sprains, and muscle strains.

Use:

For the temporary relief of minor muscle pain, simple back aches, muscle strain or sprain.

Theraderm Pain Relieving Spray

INGREDIENTS AND APPEARANCE

THERADERM 
methyl salicylate 2-ethylbutyrate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16903-169
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B)	PEPPERMINT	12 mg  in 120 mg
METHYL SALICYLATE 2-ETHYLBUTYRATE (UNII: J8D9175Q0G) (METHYL SALICYLATE 2-ETHYLBUTYRATE - UNII:J8D9175Q0G)	METHYL SALICYLATE 2-ETHYLBUTYRATE	24 mg  in 120 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12 mg  in 120 mg
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727)	CAMPHOR OIL	5 mg  in 120 mg

Inactive Ingredients
Ingredient Name	Strength
PRUNUS PERSICA SEED (UNII: V9C81470RR)	2 mg  in 120 mg
(P-HYDROXYPHENYL)DIMETHYLSULFONIUM CHLORIDE (UNII: 33P1U651QS)	24 mg  in 120 mg
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)	1 mg  in 120 mg
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)	2 mg  in 120 mg
FRANKINCENSE OIL (UNII: 67ZYA5T02K)	2 mg  in 120 mg
MYRRH OIL (UNII: H74221J5J4)	2 mg  in 120 mg
GLYCERIN (UNII: PDC6A3C0OX)	7 mg  in 120 mg
COCONUT OIL (UNII: Q9L0O73W7L)	1 mg  in 120 mg
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)	3 mg  in 120 mg
LAVENDER OIL (UNII: ZBP1YXW0H8)	1 mg  in 120 mg
ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)	2 mg  in 120 mg
ZINGIBER CASSUMUNAR ROOT (UNII: 3NG517NPD8)	2 mg  in 120 mg

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16903-169-02	120 mg in 1 BOTTLE; Type 0: Not a Combination Product	03/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/17/2017

Labeler - Manna Omni International Incorporated (019109468)