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, Fragrance, Tocopherol

Carton Label

CARTON LABEL
(click image for full-size original)

TUBE LABEL

Tube Principal Display Panel
(click image for full-size original)

TOPICAL PAIN RELIEF
trolamine salicylate cream cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72680-005
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
SORBITAN OLIVATE
TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72680-005-02 1 TUBE in 1 CARTON contains a TUBE
1 28.4 g in 1 TUBE This package is contained within the CARTON (72680-005-02)
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 (72680-005), analysis (72680-005)

Revised: 02/2020 CBH International

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