REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM- trolamine salicylate 10% lotion

Real Time Pain Relief Therapeutic Hand Cream by

Drug Labeling and Warnings

Real Time Pain Relief Therapeutic Hand Cream by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM 
trolamine salicylate 10% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-400-15	45 mL in 1 TUBE; Type 0: Not a Combination Product	12/16/2014
2	NDC: 58133-400-04	120 mL in 1 TUBE; Type 0: Not a Combination Product	12/16/2014
3	NDC: 58133-400-12	345 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/16/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/16/2014

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Registrant - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-400)