Label: 0.025% CAPSAICIN PAIN RELIEF PATCH- capsaicin pain relief patch, capsaicin pain relief strip patch
- NDC Code(s): 85323-001-00
- Packager: Xuzhou Lanting Pharmaceutical Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 1, 2025
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0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-001-00
0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-001-00
Warnings
Warnings (For external use only)
- Do not use
- more than 1 patch at a time
- on wounds or damaged skin
- with a heating pad
- if you are allergic to any ingredients of this product
When using this product
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
Stop use and ask a doctor if
- localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- condition worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Uses
Uses For temporary relief of minor aches & pains of muscles & joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Inactive Ingredients
Glycerin, dihydroxyaluminum aminoacetate anhydrous, edetate disodium, tartaric acid, povidone K90, dmdm hydantoin, polysorbate 80, propylene glycol, carboxymethylcellulose sodium, kaolin, carbomer, sodium polyacrylate, water.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Uses For temporary relief of minor aches & pains of muscles & joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Adult and children 12 years of age and over:
clean and dry affected area
remove film from patch and apply to the skin (see illustration)
apply 1 patch at a time to affected area, not more than 3 to 4 times daily
remove patch from the skin after at most 8-hour apolication
Children under 12 years of age: consult a doctorAdult and children 12 years of age and over:
clean and dry affected area
remove film from patch and apply to the skin (see illustration)
apply 1 patch at a time to affected area, not more than 3 to 4 times daily
remove patch from the skin after at most 8-hour application
Children under 12 years of age: consult a doctor -
INGREDIENTS AND APPEARANCE
0.025% CAPSAICIN PAIN RELIEF PATCH
capsaicin pain relief patch, capsaicin pain relief strip patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:85323-001 Route of Administration TOPICAL 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 KAOLIN (UNII: 24H4NWX5CO) CARBOMER (UNII: 0A5MM307FC) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) GLYCERIN (UNII: PDC6A3C0OX) DMDM HYDANTOIN (UNII: BYR0546TOW) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) WATER (UNII: 059QF0KO0R) TARTARIC ACID (UNII: W4888I119H) POVIDONE K90 (UNII: RDH86HJV5Z) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:85323-001-00 5 in 1 BOX 03/01/2025 1 1 in 1 POUCH 1 11 g in 1 PATCH; Type 0: Not a Combination Product 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 03/01/2025 Labeler - Xuzhou Lanting Pharmaceutical Co., Ltd (457641059) Registrant - Xuzhou Lanting Pharmaceutical Co., Ltd (457641059) Establishment Name Address ID/FEI Business Operations Xuzhou Lanting Pharmaceutical Co., Ltd 457641059 manufacture(85323-001)