THERA DERM- methyl salicylate lotion 
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 Lotion

Directions:

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

Clean affected Area and rub or massage area continuously until lotion has been absoprbed into the area.

Directions: clean the affected area, then apply to pain area. Rub or massage the area continuously until the lotion has been fully absorbed into the area.

Warning: for external use only

Use only as directed. Avoid contact with the eyes and mucous membranes. DO not apply to open wounds, 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 seven days, discontinue use and consult a physician.

KEEP OUT OF THE REACH OF CHILDREN

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

Active Ingredients:

Menthol, Methyl Salicylate, Peppermint Oil, Camphor.

Inactive Ingredients

Salvia Miltiorrhiza root, Carthamus Tinctorius Flower Oil, Lavender Oil, Angelica Actiloba Flowering Top, Aloe,Zingiber Cassumunar Root Oil,Angelicae Pubescens Root,Stearic Acid, Prunus Persica Flower Bud,Notopterygium Franchetii Root,Frankincense Oil, Ligusticum Sinese Subsc, Chuanxiong Root, Myrrh,nGlycerin, Vitamin E Oil,Coconut Oil.

Purpose

The Purpose of our pain relieving Lotion is to provide temporary relief of minor aches and pains, arthritiis pain, backache, muscle aches and strains.

Indications and Usage

For the temporary relief of minor aches and pains, arthritis pain, backache,muscle vstrains and sprains. Make sure to clean the affected area then apply lotion and rub into the skin until it absorbs.

Thera Derm Lotion

THERA DERM 
methyl salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16903-170
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR LEAF OIL (UNII: 51D0RGY52V) (CAMPHOR LEAF OIL - UNII:51D0RGY52V) CAMPHOR LEAF OIL6 mg  in 240 mg
7-AMINODESACETOXYCEPHALOSPORANIC ACID (UNII: ANM3MSM8TN) (7-AMINODESACETOXYCEPHALOSPORANIC ACID - UNII:ANM3MSM8TN) 7-AMINODESACETOXYCEPHALOSPORANIC ACID450 mg  in 240 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM13 mg  in 240 mg
METHYL SALICYLATE 2-ETHYLBUTYRATE (UNII: J8D9175Q0G) (METHYL SALICYLATE 2-ETHYLBUTYRATE - UNII:J8D9175Q0G) METHYL SALICYLATE 2-ETHYLBUTYRATE28 mg  in 240 mg
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL13 mg  in 240 mg
Inactive Ingredients
Ingredient NameStrength
PAEONIA LACTIFLORA FLOWER (UNII: R73687A534) 4 mg  in 240 mg
SALVIA MILTIORRHIZA ROOT (UNII: 1693AM5SBN) 4 mg  in 240 mg
ANGELICA SINENSIS ROOT OIL (UNII: T8CL3168L1) 4 mg  in 240 mg
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97) 4 mg  in 240 mg
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S) 15 mg  in 240 mg
MYRRH OIL (UNII: H74221J5J4) 4 mg  in 240 mg
LAVENDER OIL (UNII: ZBP1YXW0H8) 3 mg  in 240 mg
PERSICARIA FILIFORMIS FLOWERING TOP (UNII: M4VKX9Q8AJ) 4 mg  in 240 mg
NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI) 4 mg  in 240 mg
ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ) 4 mg  in 240 mg
ZINGIBER CASSUMUNAR ROOT OIL (UNII: O47HX41O6C) 4 mg  in 240 mg
COCONUT OIL (UNII: Q9L0O73W7L) 4 mg  in 240 mg
ALOE (UNII: V5VD430YW9) 7.5 mg  in 240 mg
CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5) 4 mg  in 240 mg
FRANKINCENSE OIL (UNII: 67ZYA5T02K) 4 mg  in 240 mg
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16903-170-03240 mg in 1 BOTTLE; Type 0: Not a Combination Product10/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/31/2017
Labeler - Manna Omni International Incorporated (019109468)
Registrant - Manna Omni International Incorporated (019109468)
Establishment
NameAddressID/FEIBusiness Operations
Manna Omni International Incorporated019109468manufacture(16903-170)

Revised: 2/2018
Document Id: 65986bc2-c2e7-345e-e053-2991aa0ad094
Set id: 5a5a8ce6-2c7b-e078-e053-2991aa0a0e3a
Version: 2
Effective Time: 20180219
 
Manna Omni International Incorporated