Topical Pain Relief: Package Insert and Label Information

TOPICAL PAIN RELIEF- trolamine salicylate cream
CBH International

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

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, Emu Oil, Fragrance, Tocopherol

TOPICAL PAIN RELIEF trolamine salicylate cream cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72680-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TROLAMINE SALICYLATE (SALICYLIC ACID) TROLAMINE SALICYLATE 100 mg in 1 g

Inactive Ingredients Ingredient Name Strength YELLOW WAX CANNABIS SATIVA SEED OIL CARTHAMUS TINCTORIUS SEED OLEOSOMES CETEARYL OLIVATE COCONUT OIL EMU OIL SORBITAN OLIVATE TOCOPHEROL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72680-001-02 1 TUBE in 1 CARTON contains a TUBE 1 28.4 g in 1 TUBE This package is contained within the CARTON (72680-001-02)

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	Operations
TAKA USA, Inc. dba Cosmetic Innovations		802860515	manufacture (72680-001), analysis (72680-001)

Revised: 01/2021 CBH International