OSTEOBIOS- calcitonin human - calcium carbonate - calcium fluoride - calcium phosphate - isoleucine - leucine - lysine - methionine - phenylalanine - sus scrofa bone - sus scrofa parathyroid gland - threonine - tryptophan - valine - solution/ drops
Guna spa

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.

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OSTEOBIOS

ACTIVE INGREDIENTS/PURPOSE

BONE 10X 30X 200X BONE FRACTURES

CALCAREA FLUORICA 12X 30X 200X BONE FRACTURES

CALCAREA CARBONICA 12X 30X 200X BONE FRACTURES

CALCAREA PHOSPHORICA 12X 30X 200X BONE FRACTURES

CALCITONIN 6X BONE FRACTURES

PARATHYROID GLAND 10X 30X 200X IMPROVES BONE REPAIR

USES

Temporary relief of symptoms related weak bones such as:

Frequent and slow-healing fractures
Sharp and dull bone pain

WARNINGS

Stop use and ask doctor if symptoms persist more than 5 days.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Contains ethyl alcohol 30%

PREGNANCY

If pregnant or breast-feeding ask a doctor before use

WARNINGS

Keep out of reach of children

DIRECTIONS

Adults and children 12 years and older 20 drops in a little water, 2 times per day

Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day

Children under 6 years 5 drops in a glass of water, 2 times per day

QUESTIONS

Questions?: info@gunainc.com, tel. (484) 223-3500

Inactive ingredient: Ethyl alcohol 30%.

Take 15 minutes before meals

PRINCIPAL DISPLAY PANEL

5USOST-REV05-03-04-18

OSTEOBIOS
calcitonin human - calcium carbonate - calcium fluoride - calcium phosphate - isoleucine - leucine - lysine - methionine - phenylalanine - sus scrofa bone - sus scrofa parathyroid gland - threonine - tryptophan - valine - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-259
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCITONIN HUMAN (UNII: I0IO929019) (CALCITONIN HUMAN - UNII:I0IO929019)	CALCITONIN HUMAN	6 [hp_X] in 30 mL
ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77)	ISOLEUCINE	3 [hp_X] in 30 mL
LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C)	LEUCINE	3 [hp_X] in 30 mL
LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6)	LYSINE	3 [hp_X] in 30 mL
METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL)	METHIONINE	3 [hp_X] in 30 mL
PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R)	PHENYLALANINE	3 [hp_X] in 30 mL
THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S)	THREONINE	3 [hp_X] in 30 mL
TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX)	TRYPTOPHAN	3 [hp_X] in 30 mL
VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7)	VALINE	3 [hp_X] in 30 mL
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	30 [hp_X] in 30 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	30 [hp_X] in 30 mL
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM PHOSPHATE	30 [hp_X] in 30 mL
SUS SCROFA BONE (UNII: 597RLJ09RG) (SUS SCROFA BONE - UNII:597RLJ09RG)	SUS SCROFA BONE	30 [hp_X] in 30 mL
SUS SCROFA PARATHYROID GLAND (UNII: 2KBE35NE8S) (SUS SCROFA PARATHYROID GLAND - UNII:2KBE35NE8S)	SUS SCROFA PARATHYROID GLAND	30 [hp_X] in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)	9 mL in 30 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-259-18	1 in 1 BOX	05/01/2018
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/23/2006

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-259)