Label: GROWTH HORMONE spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 63776-700-11, 63776-700-14, 63776-700-15, 63776-700-16, view more63776-700-17 - Packager: VIATREXX BIO INCORPORATED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 11, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose:
- Description
- Uses
- Warnings
- Dosage
- Product Availability
- Inactive Ingredients
- Other Information
-
References Upon Request
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Distributed by Viatrexx Bio Incorporated
Newark, DE, USA, 19713
Manufactured by
8046255 Canada Inc
Beloeil, Qc, J3G 6S3
Date of last revision March 2019
For questions and comments
Info@Viatrexx.com
www.Viatrexx.com -
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 63776-700-11
Item: VPC0085
Viatrexx Bio Incorporated
Viatrexx- Growth Hormone
Box of 1 X 0.5 mL ampule
For Oral and Topical Use
Expiry date: Lot #:
Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com
Inactives: Alcohol 20%, Water 80%NDC: 63776-700-14
Item: VPC0085
Viatrexx Bio Incorporated
Viatrexx- Growth Hormone
Box of 1 X 30 mL spray bottle
For Oral and Topical Use
Expiry date: Lot #:
Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com
Inactives: Alcohol 20%, Water 80%NDC: 63776-700-15
Item: VPC0085
Viatrexx Bio Incorporated
Viatrexx- Growth Hormone
Box of 1 X 50 mL spray bottle
For Oral and Topical Use
Expiry date: Lot #:
Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com
Inactives: Alcohol 20%, Water 80%NDC: 63776-700-16
Item: VPC0085
Viatrexx Bio Incorporated
Viatrexx- Growth Hormone
Box of 1 X 100 mL bottle
For Oral and Topical Use
Expiry date: Lot #:
Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com
Inactives: Alcohol 20%, Water 80%NDC: 63776-700-17
Item: VPC0085
Viatrexx Bio Incorporated
Viatrexx- Growth Hormone
Box of 1 X 250 mL bottle
For Oral and Topical Use
Expiry date: Lot #:
Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com
Inactives: Alcohol 20%, Water 80% -
INGREDIENTS AND APPEARANCE
GROWTH HORMONE
growth hormone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63776-700 Route of Administration ORAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Somatropin (UNII: NQX9KB6PCL) (Somatropin - UNII:NQX9KB6PCL) Somatropin 200 [kp_C] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63776-700-11 1 in 1 BOX 08/21/2019 1 0.5 mL in 1 AMPULE; Type 0: Not a Combination Product 2 NDC:63776-700-14 1 in 1 BOX 08/21/2019 2 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 3 NDC:63776-700-15 1 in 1 BOX 08/21/2019 3 50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 4 NDC:63776-700-16 1 in 1 BOX 08/21/2019 4 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:63776-700-17 1 in 1 BOX 08/21/2019 5 250 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/24/2012 Labeler - VIATREXX BIO INCORPORATED (078419880) Establishment Name Address ID/FEI Business Operations 8046255 Canada Inc 200651455 api manufacture(63776-700) , label(63776-700) , manufacture(63776-700) , pack(63776-700) Establishment Name Address ID/FEI Business Operations Les Importations Herbasante Inc 243254612 manufacture(63776-700)