OTC - PURPOSE SECTION.

Purpose. Topical Analgesic.

INDICATIONS & USAGE SECTION.

Uses. For the temporary relief of minor aches and pains of muscles and joints associated with:Arthritis Simple BackacheStrainsSprainsBruises. Arthritis Simple Backache. Strains. Sprains. Bruises.

OTC - ACTIVE INGREDIENT SECTION.

Active Ingredient. Capsaicin 0.1%.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep Out of the Reach of Children. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION.

Directions. Adults and Children over 18 years:Apply to affected areaMassage into the painful area until thoroughly absorbedRepeat as necessary but not more than to times dailyWASH HANDS WITH SOAP AND WATER AFTER APPLYINGChildren 18 years and younger: Ask doctor. Apply to affected area. Massage into the painful area until thoroughly absorbed. Repeat as necessary but not more than to times daily. WASH HANDS WITH SOAP AND WATER AFTER APPLYING.

INACTIVE INGREDIENT SECTION.

Inactive Ingredients. Aloe barbadensis leaf juice, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Purified Water, stearic acid.

OTC - PREGNANCY OR BREAST FEEDING SECTION.

If Pregnant or Breast Feeding. Ask doctor before use.

OTC - QUESTIONS SECTION.

Questions. Call 1-800-645-2158Distributed By:RUGBY(R)LABORATORIESLivonia, MI 48152www.rugbylaboratories.comrev. 09/21 R-167 Re-order No. 370818.

OTC - STOP USE SECTION.

Stop Use and Ask Doctor. Stop Use and Ask Doctor if:Condition worsensSymptoms persist for more than days or clear up and occur again within few daysRedness is presentirritation develops. Condition worsens. Symptoms persist for more than days or clear up and occur again within few days. Redness is present. irritation develops.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Packaging. 5882244 CAH RGB Capsaicin Cream 42.5g CDER.

SPL UNCLASSIFIED SECTION.

Drug Facts.

STORAGE AND HANDLING SECTION.

Other Information. Store at room temperature 15-30F (59-86F).

WARNINGS SECTION.

Warnings. For external use only: TEST FIRST ON SMALL AREA OF SKIN. When using this product:Use only as directedDo not apply to wounds, damaged, broken or irritated sinDo not use if you are allergic to capssicum or chili peppersAvoid contact with the eyes or mucous membranesA slight burning sensation may occur upon application, but generally disappears after several days of useIf severe burning occurs, discontinue useDo not expose the treated area to heat or direct sunlightDo not bandageDo not use with heating pad. Use only as directed. Do not apply to wounds, damaged, broken or irritated sin. Do not use if you are allergic to capssicum or chili peppers. Avoid contact with the eyes or mucous membranes. slight burning sensation may occur upon application, but generally disappears after several days of use. If severe burning occurs, discontinue use. Do not expose the treated area to heat or direct sunlight. Do not bandage. Do not use with heating pad.