TOPICAL PAIN RELIEF- trolamine salicylate cream cream

Topical Pain Relief by

Drug Labeling and Warnings

Topical Pain Relief by is a Otc medication manufactured, distributed, or labeled by CBH International, TAKA USA, Inc. dba Cosmetic Innovations. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Trolamine salicylate 10%

Purpose

Antiacne medication

Uses

Temporary releif of minor aches and pains of musclesand joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

For external use only

When using this product

Avoid contact with eyes

Do not apply to wounds or damaged skin

Do not bandage tightly

Stop use and ask a doctor if

Conditons worsen

Symptoms persist for more than 7 days or clear up and occur again withina few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Consult a doctor.

Other Information

Store at room temperature. Avoid excessive heat.

Inactive Ingredients

Beeswax, Cannabis Sativa Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Olivate, Cocos Nucifera (Coconut) Oil, Fragrance, Tocopherol

Carton Label

TUBE LABEL

INGREDIENTS AND APPEARANCE

TOPICAL PAIN RELIEF 
trolamine salicylate cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72680-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
COCONUT OIL (UNII: Q9L0O73W7L)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72680-005-02	1 in 1 CARTON	01/14/2019
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/14/2019

Labeler - CBH International (116834275)

Establishment
Name	Address	ID/FEI	Business Operations
TAKA USA, Inc. dba Cosmetic Innovations		802860515	manufacture(72680-005) , analysis(72680-005)