REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM- trolamine salicylate 10% lotion 
Cosmetic Specialty Labs, Inc.

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:

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

labeling

REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM 
trolamine salicylate 10% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EMU OIL (UNII: 344821WD61)  
LAURETH-7 (UNII: Z95S6G8201)  
BUTYROSPERMOL (UNII: 6SF0L0FL42)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOL (UNII: Y050HYR4XA)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-400-1545 mL in 1 TUBE; Type 0: Not a Combination Product12/16/2014
2NDC:58133-400-04120 mL in 1 TUBE; Type 0: Not a Combination Product12/16/2014
3NDC:58133-400-12345 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/16/2014
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/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-400)

Revised: 1/2018
Document Id: 61e1af5e-d783-a3b6-e053-2a91aa0ad098
Set id: 61e1af5e-d782-a3b6-e053-2a91aa0ad098
Version: 1
Effective Time: 20180103
 
Cosmetic Specialty Labs, Inc.