Label: RUGBY ARTHRITIS PAIN RELIEVING TOPICAL ANALGESIC- capsaicin cream
- NDC Code(s): 0536-1118-25
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated May 26, 2017
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
Read all warnings and directions before use. TEST FIRST ON SMALL AREA OF SKIN.
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 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 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.
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
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 57 g Tube Carton
INGREDIENTS AND APPEARANCE
RUGBY ARTHRITIS PAIN RELIEVING TOPICAL ANALGESIC
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin 0.75 mg in 1 g Inactive Ingredients Ingredient Name Strength Benzyl Alcohol (UNII: LKG8494WBH) Cetyl Alcohol (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Isopropyl Myristate (UNII: 0RE8K4LNJS) PEG-100 Stearate (UNII: YD01N1999R) Petrolatum (UNII: 4T6H12BN9U) Sorbitol (UNII: 506T60A25R) Water (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1118-25 1 in 1 CARTON 05/24/2017 1 57 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 05/24/2017 Labeler - Rugby Laboratories (079246066) Registrant - Garcoa, Inc (036464697) Establishment Name Address ID/FEI Business Operations Garcoa, Inc 036464697 MANUFACTURE(0536-1118)