Active ingredient

Ask a doctor

Do not use

Keep out of reach of children

Pregnancy warning

Purpose

Storage

Precautions

Inactive ingredient

Uses- Gingi-Pak Z-Twist

Uses Uses

Direction

For topical use only

Warning

Uses- Gingi-Pak Soft-Twist

Uses- Gingi-Pak 2-ply

Uses- Crown-Pak 4-ply

Principal display- Gingi-Pak No 00

Principle display- Gingi-Pak No 00

Principal display- Gingi-Pak No 1

Principle display- Gingi-Pak No 1

Principal display- Gingi-Pak No 2

Principle display- Gingi-Pak No 2

Principal display- Gingi-Pak No 3

Principle display- Gingi-Pak No 3

Principal display-Soft-Twist NO1

Principal display-Soft-Twist NO2

Principal display-Soft-Twist NO3

Principal display-2-ply

Principal display-4-ply

Principal display-Gingi-Pak Cotton Coil

Gingi-Pak Cotton Coil

Principal display-Gingi-Pak Pellets

Gingi-Pak Pellets

GINGI-PAK MAX SOFT-TWIST NO 1
dl epinephrine hci solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-001
Route of Administration	DENTAL, SUBGINGIVAL, PERIODONTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	0.197 mg in 10 mm

Ingredient Name	Strength
Inactive Ingredients
COTTON FIBER (UNII: 70LDW53ROO)	10 mm in 10 mm
SODIUM DITHIONITE (UNII: 2K5B8F6ES1)	6.15 ug in 10 mm
EDETIC ACID (UNII: 9G34HU7RV0)	0.033 ug in 10 mm
METHYLPARABEN (UNII: A2I8C7HI9T)	1.65 ug in 10 mm
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.813 ug in 10 mm
SODIUM CHLORIDE (UNII: 451W47IQ8X)	8.13 ug in 10 mm
SODIUM THIOSULFATE (UNII: HX1032V43M)	2.46 ug in 10 mm
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)	6.15 ug in 10 mm

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-001-03	2740 mm in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/26/1987

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/26/1987

GINGI-PAK MAX SOFT-TWIST NO 2
dl epinephrine hci solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-002
Route of Administration	PERIODONTAL, DENTAL, SUBGINGIVAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	0.197 mg in 10 mm

Ingredient Name	Strength
Inactive Ingredients
COTTON FIBER (UNII: 70LDW53ROO)	10 mm in 10 mm
SODIUM DITHIONITE (UNII: 2K5B8F6ES1)	6.15 ug in 10 mm
EDETIC ACID (UNII: 9G34HU7RV0)	0.033 ug in 10 mm
METHYLPARABEN (UNII: A2I8C7HI9T)	1.65 ug in 10 mm
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.813 ug in 10 mm
SODIUM CHLORIDE (UNII: 451W47IQ8X)	8.13 ug in 10 mm
SODIUM THIOSULFATE (UNII: HX1032V43M)	2.46 ug in 10 mm
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)	6.15 ug in 10 mm

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-002-03	2740 mm in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/11/1985

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		01/11/1985

GINGI-PAK MAX Z-TWIST NO 1
dl epinephrine hci solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-052
Route of Administration	DENTAL, SUBGINGIVAL, PERIODONTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	0.197 mg in 10 mm

Ingredient Name	Strength
Inactive Ingredients
COTTON FIBER (UNII: 70LDW53ROO)	10 mm in 10 mm
SODIUM DITHIONITE (UNII: 2K5B8F6ES1)	6.15 ug in 10 mm
EDETIC ACID (UNII: 9G34HU7RV0)	0.033 ug in 10 mm
SODIUM THIOSULFATE (UNII: HX1032V43M)	2.46 ug in 10 mm
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)	6.15 ug in 10 mm
SODIUM CHLORIDE (UNII: 451W47IQ8X)	8.13 ug in 10 mm
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.813 ug in 10 mm
METHYLPARABEN (UNII: A2I8C7HI9T)	1.65 ug in 10 mm

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-052-01	2740 mm in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/24/1995

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/24/1995

GINGI-PAK MAX Z-TWIST NO 2
dl epinephrine hci solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-053
Route of Administration	DENTAL, SUBGINGIVAL, PERIODONTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	0.197 mg in 10 mm

Ingredient Name	Strength
Inactive Ingredients
COTTON FIBER (UNII: 70LDW53ROO)	10 mm in 10 mm
SODIUM DITHIONITE (UNII: 2K5B8F6ES1)	6.15 ug in 10 mm
EDETIC ACID (UNII: 9G34HU7RV0)	0.033 ug in 10 mm
SODIUM THIOSULFATE (UNII: HX1032V43M)	2.46 ug in 10 mm
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)	6.15 ug in 10 mm
SODIUM CHLORIDE (UNII: 451W47IQ8X)	8.13 ug in 10 mm
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.813 ug in 10 mm
METHYLPARABEN (UNII: A2I8C7HI9T)	1.65 ug in 10 mm

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-053-01	2740 mm in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/24/1995

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/24/1995

GINGI-PAK MAX Z-TWIST NO 3
dl epinephrine hci solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-054
Route of Administration	SUBGINGIVAL, DENTAL, PERIODONTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	0.197 mg in 10 mm

Ingredient Name	Strength
Inactive Ingredients
COTTON FIBER (UNII: 70LDW53ROO)	10 mm in 10 mm
SODIUM DITHIONITE (UNII: 2K5B8F6ES1)	6.15 ug in 10 mm
EDETIC ACID (UNII: 9G34HU7RV0)	0.033 ug in 10 mm
SODIUM THIOSULFATE (UNII: HX1032V43M)	2.46 ug in 10 mm
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)	6.15 ug in 10 mm
SODIUM CHLORIDE (UNII: 451W47IQ8X)	8.13 ug in 10 mm
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.813 ug in 10 mm
METHYLPARABEN (UNII: A2I8C7HI9T)	1.65 ug in 10 mm

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-054-01	2740 mm in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/24/1995

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/24/1995

GINGI-PAK MAX 2-PLY
dl epinephrine hci solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-004
Route of Administration	PERIODONTAL, DENTAL, SUBGINGIVAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	0.197 mg in 10 mm

Ingredient Name	Strength
Inactive Ingredients
COTTON FIBER (UNII: 70LDW53ROO)	10 mm in 10 mm
SODIUM DITHIONITE (UNII: 2K5B8F6ES1)	6.15 ug in 10 mm
EDETIC ACID (UNII: 9G34HU7RV0)	0.033 ug in 10 mm
METHYLPARABEN (UNII: A2I8C7HI9T)	1.65 ug in 10 mm
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.813 ug in 10 mm
SODIUM CHLORIDE (UNII: 451W47IQ8X)	8.13 ug in 10 mm
SODIUM THIOSULFATE (UNII: HX1032V43M)	2.46 ug in 10 mm
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)	6.15 ug in 10 mm

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-004-03	2740 mm in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/29/1984

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/29/1984

GINGI-PAK MAX Z-TWIST NO 00
dl epinephrine hci solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-051
Route of Administration	DENTAL, SUBGINGIVAL, PERIODONTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	0.197 mg in 10 mm

Ingredient Name	Strength
Inactive Ingredients
COTTON FIBER (UNII: 70LDW53ROO)	10 mm in 10 mm
SODIUM DITHIONITE (UNII: 2K5B8F6ES1)	6.15 ug in 10 mm
EDETIC ACID (UNII: 9G34HU7RV0)	0.033 ug in 10 mm
SODIUM THIOSULFATE (UNII: HX1032V43M)	2.46 ug in 10 mm
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)	6.15 ug in 10 mm
SODIUM CHLORIDE (UNII: 451W47IQ8X)	8.13 ug in 10 mm
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.813 ug in 10 mm
METHYLPARABEN (UNII: A2I8C7HI9T)	1.65 ug in 10 mm

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-051-01	2740 mm in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/24/1995

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/24/1995

GINGI-PAK MAX SOFT-TWIST NO 3
dl epinephrine hci solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-003
Route of Administration	PERIODONTAL, DENTAL, SUBGINGIVAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	0.197 mg in 10 mm

Ingredient Name	Strength
Inactive Ingredients
COTTON FIBER (UNII: 70LDW53ROO)	10 mm in 10 mm
SODIUM DITHIONITE (UNII: 2K5B8F6ES1)	6.15 ug in 10 mm
EDETIC ACID (UNII: 9G34HU7RV0)	0.033 ug in 10 mm
METHYLPARABEN (UNII: A2I8C7HI9T)	1.65 ug in 10 mm
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.813 ug in 10 mm
SODIUM CHLORIDE (UNII: 451W47IQ8X)	8.13 ug in 10 mm
SODIUM THIOSULFATE (UNII: HX1032V43M)	2.46 ug in 10 mm
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)	6.15 ug in 10 mm

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-003-03	2740 mm in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/11/1985

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		01/11/1985

CROWN-PAK MAX 4-PLY
dl epinephrine hci solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-005
Route of Administration	PERIODONTAL, DENTAL, SUBGINGIVAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	0.197 mg in 10 mm

Ingredient Name	Strength
Inactive Ingredients
COTTON FIBER (UNII: 70LDW53ROO)	10 mm in 10 mm
SODIUM DITHIONITE (UNII: 2K5B8F6ES1)	6.15 ug in 10 mm
EDETIC ACID (UNII: 9G34HU7RV0)	0.033 ug in 10 mm
METHYLPARABEN (UNII: A2I8C7HI9T)	1.65 ug in 10 mm
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.813 ug in 10 mm
SODIUM CHLORIDE (UNII: 451W47IQ8X)	8.13 ug in 10 mm
SODIUM THIOSULFATE (UNII: HX1032V43M)	2.46 ug in 10 mm
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)	6.15 ug in 10 mm

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-005-03	2740 mm in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/29/1984

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/29/1984

GINGI-PAK COTTON COIL
dl epinephrine hci solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-008
Route of Administration	PERIODONTAL, DENTAL, SUBGINGIVAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	1.18 mg in 10 mm

Ingredient Name	Strength
Inactive Ingredients
COTTON FIBER (UNII: 70LDW53ROO)	10 mm in 10 mm
SODIUM DITHIONITE (UNII: 2K5B8F6ES1)	6.15 ug in 10 mm
EDETIC ACID (UNII: 9G34HU7RV0)	0.033 ug in 10 mm
METHYLPARABEN (UNII: A2I8C7HI9T)	1.65 ug in 10 mm
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.813 ug in 10 mm
SODIUM CHLORIDE (UNII: 451W47IQ8X)	8.13 ug in 10 mm
SODIUM THIOSULFATE (UNII: HX1032V43M)	2.46 ug in 10 mm
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)	6.15 ug in 10 mm

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-008-01	610 mm in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/26/1987

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/26/1987

GINGI-PAK PELLETS
dl epinephrine hci solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-007
Route of Administration	PERIODONTAL, DENTAL, SUBGINGIVAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	0.7 mg

Ingredient Name	Strength
Inactive Ingredients
SODIUM DITHIONITE (UNII: 2K5B8F6ES1)	2.38 ug
EDETIC ACID (UNII: 9G34HU7RV0)	0.013 ug
METHYLPARABEN (UNII: A2I8C7HI9T)	0.638 ug
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.314 ug
SODIUM CHLORIDE (UNII: 451W47IQ8X)	3.14 ug
SODIUM THIOSULFATE (UNII: HX1032V43M)	0.95 ug
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)	2.38 ug

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-007-02	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/26/1987

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/26/1987

Labeler - Gingi-Pak a Division of the Belport (008480121)

Registrant - Jeff Nichols (008480121)

Name	Address	ID/FEI	Business Operations
Establishment
Gingi-Pak a Division of the Belport		008480121	manufacture(10129-051, 10129-052, 10129-053, 10129-054, 10129-001, 10129-002, 10129-003, 10129-004, 10129-005, 10129-007, 10129-008)

Gingi-Pak Retraction Cord