RUGBY CAPSAICIN EXTERNAL ANALGESIC- capsaicin cream
A-S Medication Solutions

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.

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Rugby® Capsaicin Cream
External Analgesic

Drug Facts

Active ingredient

Capsaicin 0.025%

Purpose

External analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to:

simple backache
arthritis
strains
sprains

Warnings

For external use only

Read all warnings and directions before use. Test first on small area of skin.

Do not use

on wounds or damaged skin
if you are allergic to capsicum or chili peppers

When using this product

you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
avoid contact with the eyes, lips, nose and mucous membranes
do not tightly wrap or bandage the treated area
do not apply heat to the treated area immediately before or after use

Stop use and ask a doctor if

condition worsens or does not improve after regular use
severe burning persists or blistering occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 18 years of age and older:

apply a thin film of cream to affected area and gently rub in until fully absorbed
unless treating hands, wash hands thoroughly with soap and water immediately after application
for best results, apply 3 to 4 times daily.

Children under 18 years: ask a doctor

Other information

store at room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, cetyl acetate, methylparaben, PPG-20 methyl glucose ether distearate, propylene glycol, propylparaben, stearate-100, stearic acid, stearyl alcohol, triethanolamine, water

Questions or comments?

Call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday

Mfd for:
Rugby Laboratories, Inc.
Duluth, Georgia 30097

HOW SUPPLIED

Product: 50090-2293

Capsaicin

RUGBY CAPSAICIN EXTERNAL ANALGESIC
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50090-2293(NDC:0536-2525)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
Cetyl Acetate (UNII: 4Q43814HXS)
Methylparaben (UNII: A2I8C7HI9T)
PPG-20 Methyl Glucose Ether Distearate (UNII: 0057334FAB)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Steareth-100 (UNII: 4OH5W9UM87)
Stearic Acid (UNII: 4ELV7Z65AP)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Trolamine (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50090-2293-0	1 in 1 CARTON	02/05/2016	03/31/2019
1		60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	03/01/2012	03/31/2019

Labeler - A-S Medication Solutions (830016429)

Name	Address	ID/FEI	Business Operations
Establishment
A-S Medication Solutions		830016429	RELABEL(50090-2293)

Revised: 1/2020

Document Id: c5f30b73-7743-4140-a12b-b5f68c5cd760

Set id: e2848eb2-2566-483a-b422-fbdb25e210df

Version: 7

Effective Time: 20200118

A-S Medication Solutions

Rugby® Capsaicin Cream External Analgesic