Label: DEODORANT- triclocarban soap
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Contains inactivated NDC Code(s)
NDC Code(s): 53507-001-01, 53507-001-02, 53507-001-03, 53507-001-04, view more53507-001-05, 53507-001-06, 53507-001-07, 53507-001-08, 53507-001-09, 53507-001-10, 53507-001-11, 53507-001-12, 53507-001-13, 53507-001-14, 53507-001-15, 53507-001-16, 53507-001-17 - Packager: Shanghai Kangyi Tourism Products 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 May 26, 2014
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- Active Ingredient
- Use
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WARNINGS
For external use only. Keep out of reach of children.
Children should use only this product under adult supervision.
Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Avoid contact with broken skin.
When using this product, avoid contact with eyes. In case of eye contact, immediately flush eyes with water, call a doctor.
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DEODORANT
triclocarban soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53507-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y) TRICLOCARBAN 0.29 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Sodium Palmate (UNII: S0A6004K3Z) Sodium Cocoate (UNII: R1TQH25F4I) Calcium Carbonate (UNII: H0G9379FGK) Glycerin (UNII: PDC6A3C0OX) Sodium Chloride (UNII: 451W47IQ8X) Edetate Sodium (UNII: MP1J8420LU) Etidronic Acid (UNII: M2F465ROXU) Titanium Dioxide (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53507-001-01 10 g in 1 PACKAGE 2 NDC:53507-001-02 13 g in 1 PACKAGE 3 NDC:53507-001-03 20 g in 1 PACKAGE 4 NDC:53507-001-04 30 g in 1 PACKAGE 5 NDC:53507-001-05 35 g in 1 PACKAGE 6 NDC:53507-001-06 54 g in 1 PACKAGE 7 NDC:53507-001-07 60 g in 1 PACKAGE 8 NDC:53507-001-08 75 g in 1 PACKAGE 9 NDC:53507-001-09 85 g in 1 PACKAGE 10 NDC:53507-001-10 14.17 g in 1 PACKAGE 11 NDC:53507-001-11 21.26 g in 1 PACKAGE 12 NDC:53507-001-12 28.35 g in 1 PACKAGE 13 NDC:53507-001-13 42.52 g in 1 PACKAGE 14 NDC:53507-001-14 71 g in 1 PACKAGE 15 NDC:53507-001-15 99 g in 1 PACKAGE 16 NDC:53507-001-16 113 g in 1 PACKAGE 17 NDC:53507-001-17 142 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/24/2012 Labeler - Shanghai Kangyi Tourism Products Co., Ltd. (531054513) Establishment Name Address ID/FEI Business Operations Shanghai Kangyi Tourism Products Co., Ltd. 531054513 manufacture(53507-001)