Synofilm: Product Information

SYNOFILM- lactic acid liquid
Quat-Chem Ltd.

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.

Synofilm

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WARNING
Causes serious eye irritation.
Wash affected area thoroughly after handling.
Wear protective gloves/protective clothing/eye protection/face protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice/attention.
Shake well before use.
Store in ambient temperatures.

DO NOT MIX WITH OTHER CHEMICALS
FOR EXTERNAL USE ONLY
FOR PROFESSIONAL COMMERCIAL USE
ONLY.
NOT FOR HUMAN USE.
KEEP OUT OF THE REACH OF CHILDREN.

Quat-Chem Ltd.
1-4 Sandfield Industrial Park,
Dodgson Street,
Rochdale, Greater Manchester
United Kingdom
OL16 5SJ
www.quatchem.com
sales@quatchem.co.uk
Tel: +44(0)1706 344 797

EN ISO 9001:2008 QMS
GMP ISO 22716:2007

Manufactured in the UK

DESCRIPTION
▪ Formulation contains a 12% specially balanced emollient blend
▪ Includes Lanolin, Glycerine and natural citrus oils
▪ Reduces dehydration of the epidermis, enhancing the condition of the teat
▪ Extremely effective broad-spectrum disinfectant
▪ Formulation does not require dilution in preparation for dipping the teat

DIRECTIONS FOR USE
Post-Milking: Use a clean teat dipping cup after every milking. Fill dipping cup two thirds full.
Immerse teat in dipping cup ensuring full coverage of the teat. Film residue is easily removed prior to next milking.

ANTIMICROBIAL EFFICACY
Synofilm passes EN 1656:2000 (phase 2/step 1) Quantitative Test for the evaluation of Bactericidal Activity of Chemical Disinfectants and Antiseptics used in the Veterinary and Agricultural Fields,
giving > 99.999% kill for the following environmental organisms frequently implicated in common
teat infections.
– Streptococcus dysgalactiae
– Streptococcus uberis
– Streptococcus agalactiae
– Staphylococcus epidermidis
– Staphylococcus aureus
– Escherichia coli
– Enterococcus hirae

Active Ingredients: 8% Lactic Acid

See Packaging For:
Manu Manufactured Date
Expiration DateBatch Numbe

NDC Number:

Synofilm representative label

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(click image for full-size original)

SYNOFILM teat dip liquid
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:69260-009
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACTIC ACID (LACTIC ACID) LACTIC ACID 80 g in 1 L
Product Characteristics
Color yellow Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69260-009-05 5 L in 1 DRUM None
2 NDC:69260-009-25 25 L in 1 DRUM None
3 NDC:69260-009-20 200 L in 1 DRUM None
4 NDC:69260-009-10 1000 L in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/16/2016
Labeler — Quat-Chem Ltd. (458052420)
Establishment
Name Address ID/FEI Operations
Quat-Chem Ltd. 458052420 manufacture, api manufacture, label, pack

Revised: 03/2016 Quat-Chem Ltd.

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