AZTEC GOLD BASE- sodium chlorite solution

Aztec Gold Base by

Drug Labeling and Warnings

Aztec Gold Base by is a Animal medication manufactured, distributed, or labeled by IBA, Morgan Gallacher Inc. DBA in Custom Chemical Formulators Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Chlorite..................0.6%

INACTIVE INGREDIENT

INACTIVE INGREDIENT...............99.4%

Caution:

For external use only. Not for use in sanitizing dairy equipment. Do not mix with any other teat dip or other product. Avoid contact with food. Store at room temperature. Protect from heat and freezing. Always store away from continuous artificial light or direct sunlight. Avoid contact with eyes. If contact occurs, flush eyes with large quantities of water. See a physician if irritation develops. Wash thoroughly after handling.

CAUTION:

For external use only. Not for use in sanitizing dairy equipment. Do not mix with any other teat dip or other product. Avoid contact with food. Store at room temperature. Protect from heat and freezing. Always store away from continuous artificial light or direct sunlight. Avoid contact with eyes. If contact occurs, flush eyes with large quantities of water. See a physician if irritation develops. Wash thoroughly after handling.

INDICATIONS & USAGE

DIRECTIONS FOR USE: Measure equal volumes of AZTEC GOLD base and AZTEC GOLD activator into a clean dip cup/container and mix until the color is uniform throughout. Do not dilute. Mix only enough product for one milking of the herd. Dip cups should be washed after each milking.

APPLICATION:

Pre-Milking: If teats are visibly dirty, wash and dry teats with a single service towel prior to dipping. Before each cow is milked, dip the teats as far up as possible. Leave AZTEC GOLD teat dip on teats for at least 15-30 seconds. Wipe teats dry using a single service towel before milking.
Post-Milking: Immediately after milking, dip teats at least 2/3 to all their length in AZTEC GOLD Teat Dip. Allow to air dry. DO NOT WIPE OFF. AZTEC GOLD Teat Dip can be used as a post dip alone, or as a pre- and post-milking teat dip.
Always use freshly mixed, full strength AZTEC GOLD Teat Dip. If product in dip cup becomes visibly dirty, discard contents and fill with fresh AZTEC GOLD Teat Dip.

OTHER SAFETY INFORMATION

Note1: If teat irritation occurs, discontinue use until irritation subsides. Consult your veterinarian and milking equipment service personnel if irritation persists.

Note 2: The gold color in the mixed product fades with time. At higher temperatures the fading is more rapid. However this will not affect the efficacy of the product.
Note 3: AZTEC GOLD should be used only with a compatible pre-dip or udder wash.

AVOID FREEZING: If product is exposed to freezing temperatures, components must be mixed thoroughly prior to use
KEEP OUT OF REACH OF CHILDREN
NOT FOR HUMAN USE
ALWAYS SEEK IMMEDIATE MEDICAL ATTENTION
FOR MEDICAL EMERGENCIES CALL 1-800-424-9300

SPL UNCLASSIFIED SECTION

Aztec Gold Base

Aztec Gold Base

Aztec Gold Base

INGREDIENTS AND APPEARANCE

AZTEC GOLD BASE 
sodium chlorite solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 29983-0460
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORITE (UNII: G538EBV4VF) (CHLORITE ION - UNII:Z63H374SB6)	SODIUM CHLORITE	.6 kg  in 100 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29983-0460-4	19.05 kg in 1 PAIL
2	NDC: 29983-0460-6	57.15 kg in 1 DRUM
3	NDC: 29983-0460-8	209.56 kg in 1 DRUM
4	NDC: 29983-0460-9	1047.79 kg in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/25/2015

Labeler - IBA (019494160)

Registrant - IBA (019494160)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc. DBA in Custom Chemical Formulators Inc.		028311595	manufacture, api manufacture, pack