Label: RUGBY CAPSAICIN EXTERNAL ANALGESIC- capsaicin cream
- NDC Code(s): 0536-2525-25
- Packager: Rugby Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- Active ingredient
temporarily relieves minor aches and pains of muscles and joints due to:
- simple backache
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.
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 doctorClose
- Other information
store at room temperature 15° - 30°C (59° - 86°F)Close
- 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, waterClose
- Questions or comments?
Call 1-800-645-2158 9 am - 5 pm ET, Monday - FridayClose
- SPL UNCLASSIFIED SECTION
Rugby Laboratories, Inc.
Duluth, Georgia 30097
- PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
OR YOUR MONEY BACK
Capsaicin Cream, 0.025%
Penetrating Pain Relief
Net Wt 2.1 oz (60 g)
- INGREDIENTS AND APPEARANCE
RUGBY CAPSAICIN EXTERNAL ANALGESIC
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-2525 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-2525-25 1 in 1 CARTON 1 60 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 03/01/2012 Labeler - Rugby Laboratories, Inc. (191427277) Registrant - Garcoa, Inc. (103039178) Establishment Name Address ID/FEI Business Operations Garcoa, Inc. 103039178 MANUFACTURE(0536-2525)