FDA.reportPublic FDA data

OFB Emollient Concentrate EC

Manufacturer
DeLaval | WestAgro, Inc. | K Klean dba WestAgro, Inc.
Effective date
2018-06-28
Label type
OTC ANIMAL DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:53:57

Label at a glance#

ProductOFB Emollient Concentrate EC
Active ingredientGlycerin, Iodine
Label structure17 sections

Storage and handling

STORAGE AND DISPOSAL THOROUGHLY RINSE ALL MEASURING DEVICES AND STORE OUT OF REACH OF CHILDREN. Avoid contact with food or feed.  Avoid storing near heat or open flame. Keep from freezing. If product is frozen, thaw in warm room and mix well before using. Keep container tightly closed when not in use. Do not reuse empty container. Rinse empty container before disposing in a safe manner.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

An emollient concentrate designed for use with OFB Iodine Concentrate IC for on-farm blending.

Un concentrado de yodo disenado para su uso con Emollient Concentrate EC para mezclar en la finca.

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:
Emollient* ....................... 50.0%
*from Glycerin

SPL UNCLASSIFIED SECTION

1321-E0116

Emollient

Part B

NPE FREE Formula

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN
!CAUTION

MANTENER FUERA DEL ALCANCE DE LOS NINOS
!CUIDADO

SPL UNCLASSIFIED SECTION

SI USTED NO PUEDE LEER ESTA ETIQUETA, POR FAVOR PIDA A ALGUIEN MAS QUE SE LA LEA ANTES DE USAR ESTE PRODUCTO

READ AND UNDERSTAND ALL INSTRUCTIONS BEFORE USING THIS PRODUCT

SPL UNCLASSIFIED SECTION

1321

SPL UNCLASSIFIED SECTION

Not for Human Use

Additional Information on Material Safety Data Sheet

SPL UNCLASSIFIED SECTION

CHEMTREC EMERGENCY NUMBER 1-800-424-9300

SPL UNCLASSIFIED SECTION

OFB Emollient Concentrate EC (Part B) is an Iodine concentrate exclusively designed for use in combination with OFB Iodine Concentrate IC (Part A) for on-farm blending / production of teat dips.  To be blended using on-farm blending equipment.

STORAGE AND HANDLING SECTION

STORAGE AND DISPOSAL

  • THOROUGHLY RINSE ALL MEASURING DEVICES AND STORE OUT OF REACH OF CHILDREN.
  • Avoid contact with food or feed.  Avoid storing near heat or open flame.
  • Keep from freezing.
  • If product is frozen, thaw in warm room and mix well before using.
  • Keep container tightly closed when not in use.
  • Do not reuse empty container.
  • Rinse empty container before disposing in a safe manner.

SPL UNCLASSIFIED SECTION

GENERAL INSTRUCTIONS

  • Do not use full-strength.
  • Consult veterinarian before starting or continuing to use teat dip if cow's teats are sore or chapped.
  • Do not use teat dip for cleaning and/or sanitizing of dairy equipment.
  • Discard any teat sanitizing solution that becomes dirty or contaminated for any reason.
  • Good dairy practices suggest the thorough cleaning and sanitizing of teats before milking to avoid contamination and assist in the control of mastitis.
  • To be mixed with OFB Iodine Concentrate IC (Part A) using programmed on-farm blending equipment.  Can be diluted to create 12 formula options.

SPL UNCLASSIFIED SECTION

FIRST AID

  • Contact with product can cause irritation to eyes.  Avoid contact with eyes.
  • Eye contact:  Flush with water.
  • If swallowed:  Do not induce vomiting.  Call a physician or poison control center immediately.

INDICATIONS & USAGE SECTION

USE DIRECTIONS

Pre-Dipping

  • Remove excess organic debris and forestrip.
  • Dip or spray cow's teats with properly diluted On-Farm Blending Concentrate.
  • Allow a 30 second contact time.
  • Dry teats thoroughly with a clean, single-service paper towel.
  • Attach milker unit.

Post-Dipping

  • Immediately after removing milker unit, dip or spray each teat with properly diluted On-Farm Blending Concentrate.
  • Before exposing cow's teats to below freezing temperatures, the teats should be thoroughly dry to reduce the potential of frostbite.  Failure to follow these instructions may result in frozen teats and injured animals.

SPL UNCLASSIFIED SECTION

DILUTION CHART
%
Emollient		0.25% Iodine0.5% Iodine0.75% Iodine1.0% Iodine
OFB
(PART A)
Iodine
Conc./
Gal.		OFB
(PART B)
Emollient
Conc./
Gal.		Water /
Gal.		OFB
(PART A)
Iodine
Conc./
Gal.		OFB
(PART B)
Emollient
Conc./
Gal.		Water /
Gal.		OFB
(PART A)
Iodine
Conc./
Gal.		OFB
(PART B)
Emollient
Conc./
Gal.		Water /
Gal.		OFB
(PART A)
Iodine
Conc./
Gal.		OFB
(PART B)
Emollient
Conc./
Gal.		Water /
Gal.
24.582.7892.659.162.0188.8313.741.2585.0218.320.4881.20
3.513.743.9082.36
54.588.0887.349.167.3283.5213.746.5679.7118.325.7975.89
104.5816.9378.499.1616.1774.7613.7415.4170.8618.3214.6467.04
1213.7418.9567.3218.3218.1863.50
1418.3221.7259.96

SPL UNCLASSIFIED SECTION

IMPORTANT!

  • 0.25% teat dip must be mixed on demand.
  • 0.5% - 1.0% teat dip must be used within two weeks after mixing.
  • Discard unused mixtures after above noted times.

SPL UNCLASSIFIED SECTION

Manufactured for: DeLaval, Inc.
11100 N. Congress Avenue
Kansas City, MO 64153
Phone: 816-891-7700
Manufactured by: WestAgro, Inc.
©2018, Made in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-137320461167160GTIN-13: 7320461167160
EAN-13: 7320461167160
GTIN storage (14 digits): 07320461167160		OFB Emollient Conc EC Label.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GlycerinACTIVE INGREDIENTPDC6A3C0OX4
IodineACTIVE INGREDIENT9679TC07X44
GlycerinACTIVE MOIETYPDC6A3C0OX4
IodineACTIVE MOIETY9679TC07X44
SODIUM IODIDEINACTIVE INGREDIENTF5WR8N145C4
WATERINACTIVE INGREDIENT059QF0KO0R4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55756-32155756-321-01, 55756-321-27

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GlycerinPDC6A3C0OXACTIB
Iodine9679TC07X4ACTIB
SODIUM IODIDEF5WR8N145CIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM IODIDESODIUM IODIDEF5WR8N145CSPONGE / TOPICAL0.74 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION / ORAL450 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM IODIDESODIUM IODIDEF5WR8N145CDOUCHE / VAGINAL0.75 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM IODIDESODIUM IODIDEF5WR8N145CINJECTION / INTRAVENOUS10 mgExact identifier — unii candidate
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 8 · 159 matching rows.

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generic name: GLYCERIN
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Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsName fallback
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SOHEJU Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.560089ff-3361-90b7-e063-6294a90ada422026-07-09WarningsName fallback
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Bee Venom Psoriasis Wart Caring CreamGLYCERINShantou Ximonth Biotechnology Co., Ltd.563a423c-e9dd-1cab-e063-6294a90a8c6a2026-07-09WarningsName fallback
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GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsName fallback
generic name: GLYCERIN
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Hair Regrowth LiquidGLYCERINShantou Woodsleep Biotechnology Co., Ltd.54e662e7-9c63-ad6b-e063-6294a90a1b8d2026-06-23WarningsName fallback
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MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsName fallback
generic name: GLYCERIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.