Real Time Pain Relief Therapeutic Hand Cream: Package Insert and Label Information

REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM- trolamine salicylate 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.

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

labeling
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TROLAMINE SALICYLATE (SALICYLIC ACID) TROLAMINE SALICYLATE 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Multilevel Packaging
1 NDC:58133-400-15 45 mL in 1 TUBE None
2 NDC:58133-400-04 120 mL in 1 TUBE None
3 NDC:58133-400-12 345 mL in 1 BOTTLE, PUMP None
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 Operations
Cosmetic Specialty Labs, Inc. 032973000 manufacture (58133-400)

Revised: 01/2018 Cosmetic Specialty Labs, Inc.

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