FDA Label for Sodium Chloride

View Indications, Usage & Precautions

HEALTH CARE PROVIDER LETTER
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sodium Chloride Product Label

The following document was submitted to the FDA by the labeler of this product Apiject Systems Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Health Care Provider Letter

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Package Label.Principal Display Panel

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Translation:

UniFlex

SODIUM CHLORIDE INJECTION
2.25g / 250ml 0.9%

Registration Approval No.: GYZZ H51021157
ATTENTION:
Visually inspect the container. Check for minute leaks by squeezing bag firmly.

If leaks are found, discard solution. Do not use the drug solution if particulate matter is visible.

[Usage] See product insert
[Storage] in a closed environment
[Packaging] UniFlex Polypropylene Bag

[LOT]
[EXP]
[MFG]

Manufacturer:
Sichuan Kelun Pharmaceutical Co., Ltd.

Translation:


Do not open with sharp object. Do not stack higher than 12 layers.	Qualification printed on flap Qualification For any quality issues or quantitative insufficiencies, please contact: Hotline: 4006860333, from Monday to Friday: 08:00-17:30, excluding official holidays. Company Website: www.kelun.com	Store as per storage requirements to ensure quality of drug products.
UniFlex Polypropylene Bag SODIUM CHLORIDE INJECTION 0.9% Registration Approval No.: GYZZH51021157 250ml Product Information LOT EXP MFG Sichuan Kelun Pharmaceutical Co., Ltd.	250ml Stack upwards, Protect from moisture and light Authorized Holder: Name: Sichuan Kelun Pharmaceutical Co., Ltd. Address: South of No. 2 Road, Xindu Satellite City Industrial Development Zone, Chengdu, Sichuan, P. R. China Manufacturer: Name: Sichuan Kelun Pharmaceutical Co., Ltd. Address: South of No. 2 Road, Xindu Satellite City Industrial Development Zone, Chengdu, Sichuan, P. R. China Postal code: 610500 Hotline: 4006860333 Company website: www.kelun.com Sichuan Kelun Pharmaceutical Co., Ltd.	UniFlex Polypropylene Bag SODIUM CHLORIDE INJECTION 0.9% Registration Approval No.: GYZZH51021157 250ml Product Information LOT EXP MFG Sichuan Kelun Pharmaceutical Co., Ltd.	250ml Stack upwards, Protect from moisture and light Product name: SODIUM CHLORIDE INJECTION (0.9%) Strength: 2.25g / 250ml Packaging: UniFlex Polypropylene Bag, 250ml/bag, 40 bags/carton Gross weight: 12 kg Volume: 485× 345 × 200 mm3 Storage: Store in an enclosed environment. Sichuan Kelun Pharmaceutical Co., Ltd.

Size: 150mmⅹ70mm

SODIUM CHLORIDE INJECTION
UniFlex Plastic Container 250 mL

"Pack size: 40 containers/carton
LOT:
EXP:
MFG:"
Storage: Store at room temperature (10°C-30°C). Do not freeze.
"Imported by:
ApiJect Systems Corp.
2 High Ridge Park, Stamford, CT 06905 USA
Tel: 855-826-4885"
Manufactured by:
Sichuan Kelun Pharmaceutical Co., Ltd.
South of No.2 Road, Xindu Satellite City Industrial Development Zone, Chengdu, Sichuan, P.R.China

* Please review the disclaimer below.

Table of Contents

Sodium Chloride Product Label

Health Care Provider Letter

Package Label.Principal Display Panel