THERA DERM ROLL ON- methyl salicylate liquid 
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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Theraderm Pain Relieving Roll On

Theraderm Roll on 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.

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.

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

Theraderm Roll on

Label Roll On

THERA DERM ROLL ON 
methyl salicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16903-171
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE 2-ETHYLBUTYRATE (UNII: J8D9175Q0G) (METHYL SALICYLATE 2-ETHYLBUTYRATE - UNII:J8D9175Q0G) METHYL SALICYLATE 2-ETHYLBUTYRATE18 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 OIL9 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 NameStrength
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
Colorwhite (Smooth Non -greasy Roll On) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16903-171-0490 mg in 1 BOTTLE; Type 0: Not a Combination Product07/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/31/2017
Labeler - Manna Omni International Incorporated (019109468)

Revised: 2/2018
Document Id: 6598841e-0d39-c3b6-e053-2a91aa0ab449
Set id: 4eb824a6-66ae-01f8-e054-00144ff8d46c
Version: 3
Effective Time: 20180219
 
Manna Omni International Incorporated