NDC | 58503-008-01 |
Set ID | 2818fc19-d7c8-4253-80d5-c61a277b1a12 |
Category | HUMAN OTC DRUG LABEL |
Packager | China Ningbo Shangge Cosmetic Technology Corp. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333E |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
Warnings
For external use only. Avoid contact with eyes.
Ask a doctor before use if you have cough associated with
- smoking
- excessive phlegm
- asthma
- emphysema
- persistent or chronic cough
When using this product do not
- heat
- microwafe
- add to hot water or any container where healing water may cause splattering and result in burns
- use in eyes or directly on mucous membranes
- take by mouth or place in nostrils
- apply to wounds or damaged skin
- bandage skin
Consult a doctor and discontinue use if condition worsesn, persists for more than 1 week or tends to recur.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HAND CLEANSE REFILL
triclosan gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 7.5 mg in 500 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58503-008-01 500 mg in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/24/2013 Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(58503-008)