Label: AGERANIUM PATCH- capsaicin patch
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Contains inactivated NDC Code(s)
NDC Code(s): 71955-100-00, 71955-100-01, 71955-100-02 - Packager: Entom Co., Ltd.
- 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.
Drug Label Information
Updated December 29, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Allergy alert: If prone to have an allergic reaction to Capsaicin, cunsult a doctor before use.
Do not use
- on wounds or damaged skin
- if you are allergic to any ingredients of this product
When using this product
- use only as directed
- avoid contact with the eyes, mucous membran, and rashes
- wrap the bandage not too tight
Stop use and ask a doctor if
- Rash, itching, or excessive skin irritation develops
- conditions worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
If pregnant or breas-feeding
- ask a health professional before use.
- Keep out of reach of children
- Directions
- Inactive ingredients
- Ageranium Patch
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INGREDIENTS AND APPEARANCE
AGERANIUM PATCH
capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71955-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.228 mg in 99.13 mg Inactive Ingredients Ingredient Name Strength POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71955-100-02 8 in 1 BOX 12/29/2017 1 NDC:71955-100-01 4 in 1 POUCH 1 NDC:71955-100-00 99.13 mg 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 not final part348 12/29/2017 Labeler - Entom Co., Ltd. (690106385) Registrant - Lanec Inc. (052790515) Establishment Name Address ID/FEI Business Operations Entom Co., Ltd. 690106385 manufacture(71955-100)