Label: GD11 RX SCM C5- mannitol liquid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated August 24, 2017
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
Warnings: For external use only
Caution in usage 1. In case of having problems such as red rash, swollenness, itching, you need to consult a dermatologist. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis 3. Caution for treatment and keeping. - Keep it out of infants or children's reach. - Don't keep it exposed to the direct sunlight
- KEEP OUT OF REACH OF CHILDREN
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
GD11 RX SCM C5
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62171-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A) MANNITOL 0.10 g in 2 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Betaine (UNII: 3SCV180C9W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62171-100-02 10 in 1 CARTON 07/01/2017 1 NDC:62171-100-01 2 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/01/2017 Labeler - Coson Co., Ltd. (689835593) Registrant - Coson Co., Ltd. (689835593) Establishment Name Address ID/FEI Business Operations COSON Co., Ltd._Osan Plant 689847210 manufacture(62171-100)