Pain Relief Cream: Package Insert and Label Information

PAIN RELIEF CREAM- trolamine salicylate cream
ALLURE 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 Ingredients:

Trolamine Salicylate — 10%

Purpose:

Topical Analgesic

Uses: For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains and bruises.

For external use only.

Ask a doctor before use if you have a propensity for allergic reactions to aspirin or salicylate.

When using this product: Avoid contact with eyes or mucous membranes; if contacts occurs, flush with water for 15 minutes. Do not apply to wounds or damaged skin.

If pain persist more than 7 days or redness or irritation is present or in condition affecting children under 12 years of age, consult a physician immediately.

Keep out of reach of children.

Inactive ingredients

Acetyl Glucosamine, Butylene Glycol, Capriylic/ Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol,Cyclopentasilaxane, Dimethicone, Dimethyl Sulfone (MSM), Disodium EDTA, Fragrance, Glyceryl Stearate, Imidazolidinyl Uraea, Isopropyl Palmitate, Lecithine, PEG-100 Stearate, Phenoxy ethanol, Potassium Sorbitate, Tocopheryl Acetate, Vanillyl Butyl Ethar, Water, Xanthan Gum.

Contains Gradual Heating Sensation. Adults and Children 12 years of age and older: use no more than 3-4 times daily. Before Activity-Massage onto muscles and joints 10-30 minutes before to warm up. After — Apply cream to sore or injured areas immediately after activity or after showering. Wash hands thoroughly with soap and water after use

Distributed by:

Flex Power Inc.

Berkeley, CA 94710

PAIN RELIEF CREAM trolamine salicylate cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4091 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 DISODIUM ACETYL GLUCOSAMINE PHOSPHATE BUTYLENE GLYCOL CETEARETH-2 DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) DIMETHICONE DIMETHYL SULFONE EDETATE DISODIUM GLYCERYL STEARATE CITRATE N-(1,3-BIS(HYDROXYMETHYL)-2,5-DIOXO-4-IMIDAZOLIDINYL)-N,N’-BIS(HYDROXYMETHYL)UREA ISOPROPYL PALMITATE LECITHIN, SOYBEAN PEG-100 STEARATE PHENOXYETHANOL VANILLYL BUTYL ETHER WATER XANTHAN GUM TOCOPHEROL MEDIUM-CHAIN TRIGLYCERIDES

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62742-4091-1 57 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/27/2017

Labeler — ALLURE LABS INC. (926831603)

Registrant — ALLURE LABS INC. (926831603)

Establishment
Name	Address	ID/FEI	Operations
ALLURE LABS INC.		926831603	manufacture (62742-4091)

Revised: 11/2017 ALLURE LABS INC.