THERADERM- methyl salicylate 2-ethylbutyrate spray 
Manna Omni International Incorporated

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Thera Derm Pain Relieving Spray

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.

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

Theraderm Spray

THERADERM 
methyl salicylate 2-ethylbutyrate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16903-169
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT12 mg  in 120 mg
METHYL SALICYLATE 2-ETHYLBUTYRATE (UNII: J8D9175Q0G) (METHYL SALICYLATE 2-ETHYLBUTYRATE - UNII:J8D9175Q0G) METHYL SALICYLATE 2-ETHYLBUTYRATE24 mg  in 120 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12 mg  in 120 mg
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL5 mg  in 120 mg
Inactive Ingredients
Ingredient NameStrength
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
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16903-169-02120 mg in 1 BOTTLE; Type 0: Not a Combination Product03/17/2017
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/17/2017
Labeler - Manna Omni International Incorporated (019109468)

Revised: 2/2018
Document Id: 65986bc2-c2f1-345e-e053-2991aa0ad094
Set id: 4ae05042-9d1b-69aa-e054-00144ff8d46c
Version: 3
Effective Time: 20180219
 
Manna Omni International Incorporated