Label: C2V LINE CLEAR- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74195-030-01 - Packager: Opseve KOREA Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
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 April 7, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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WARNINGS
Warnings:
For external use only
When using this product
■ if following abnormal symptoms persist, discontinue use
Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes
■ Stop immediately and consult a doctor if you experience
1) Hypersensitivity symptoms such as erythema, itching and dermatitis.
2) Skin Irritation
3) Following Instructions when using medication
(1) For external use only (Do not use internally)
(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)
■When used repeatedly in the same area, skin irritation may occur.
■Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.
It is not recommended to use this one areas that have been medically treated with a cast or bandage.
■Do not use in combination with soap or antibacterial cleansing agents. - KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- Other Information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
C2V LINE CLEAR
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74195-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 350 g in 500 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Butylene Glycol (UNII: 3XUS85K0RA) ALOE VERA LEAF (UNII: ZY81Z83H0X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74195-030-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/01/2020 Labeler - Opseve KOREA Co.,Ltd. (690048629) Registrant - Opseve KOREA Co.,Ltd. (690048629) Establishment Name Address ID/FEI Business Operations Opseve KOREA Co.,Ltd. 690048629 manufacture(74195-030)
