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Real Time Pain Relief Therapeutic Hand Cream

Medically reviewed on January 3, 2018

Dosage form: lotion
Ingredients: TROLAMINE SALICYLATE 10g in 100mL
Labeler: Cosmetic Specialty Labs, Inc.
NDC Code: 58133-400

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Real Time Pain Relief Therapeutic Hand Cream

Active ingredient                               Purpose

Trolamine Salicylate - 10%                Topical Analgesic

Purpose

Topical Analgesic

Uses

Uses: ​temporarily relieves minor pain associated with • arthritis • simple backache •muscle strains • bruises • cramps

Warnings
For external use only

Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

​When using this product • use only as directed • avoid contact with eyes or muscous membranes • do not apply to wounds or damaged skin

Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of the children. If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

adults and children over 2 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

children 2 years or younger: ask a doctor

Inactive ingredients:

Aloe Barbadensis Leaf, Arnica Montana Flower Extract, Butylene Glycol, Butyrospermum Parkii (Shea Butter), C13-14 Isoparaffin, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Emu Oil, Fragrance, Laureth-7, Methylsulfonylmethane, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyacrylamide, Purified Water, Salix Alba (Willow) Bark Extract, Tocopheryl Acetate, Triethanolamine.

Package Label and Principal Display Panel

REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM 
trolamine salicylate 10% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-400
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TROLAMINE SALICYLATE (SALICYLIC ACID) TROLAMINE SALICYLATE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHYL SULFONE 
ARNICA MONTANA FLOWER 
BUTYLENE GLYCOL 
.ALPHA.-TOCOPHEROL ACETATE 
CETOSTEARYL ALCOHOL 
EMU OIL 
LAURETH-7 
BUTYROSPERMOL 
C13-14 ISOPARAFFIN 
CAPRYLYL GLYCOL 
CARBOMER 940 
ALOE VERA LEAF 
CETYL ALCOHOL 
PROPYLPARABEN 
TROLAMINE 
WATER 
OLEA EUROPAEA FRUIT VOLATILE OIL 
2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOL 
POLYACRYLAMIDE (10000 MW) 
SALIX ALBA BARK 
Packaging
#Item CodePackage Description
1NDC:58133-400-1545 mL in 1 TUBE
2NDC:58133-400-04120 mL in 1 TUBE
3NDC:58133-400-12345 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/16/2014
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Registrant - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIOperations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-400)

 
Cosmetic Specialty Labs, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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