GUM THERAPY- calendula officinalis, kali phosphoricum, natrum muriaticum, arnica montana, agave americana, cistus canadensis, kr

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ), DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR), SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698), ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW), AGAVE AMERICANA LEAF (UNII: 8511ZMP5QK) (AGAVE AMERICANA LEAF - UNII:8511ZMP5QK), HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3), WOOD CREOSO
Available from:
Deseret Biologicals
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of symptoms related to gingivitis, inflamed and bleeding gums and minor pain.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration. For temporary relief of symptoms related to gingivitis, inflamed and bleeding gums and minor pain.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Authorization status:
unapproved homeopathic
Authorization number:
43742-1509-1

GUM THERAPY- calendula officinalis, kali phosphoricum, natrum muriaticum, arnica montana,

agave americana, cistus canadensis, kreosotum, myrrha, calcarea fluorica, aconitum napellus,

bismuthum subnitricum, sepia, hepar sulphuris calcareum, mercurius vivus liquid

Deseret Biologicals

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 Facts:

ACTIVE INGREDIENTS:

Calendula Officinalis 1X, 6X, 12X, 30X, Kali Phosphoricum 3X, Natrum Muriaticum 3X, Arnica

Montana 3X, 6X, 12X, 30X, Agave Americana 6X, Cistus Canadensis 6X, Kreosotum 6X, Myrrha 6X,

Calcarea Fluorica 8X, Aconitum Napellus 12X, Bismuthum Subnitricum 12X, Sepia 12X, Hepar

Sulphuris Calcareum 12X, 18X, 30X, Mercurius Vivus 12X, 18X, 30X.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to gingivitis, inflamed and bleeding gums and minor pain.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by

the Food and Drug Administration.

WARNINGS:

Keep out of reach of children. In case of overdose, Contact physician or Poison Control Center right

away.

If pregnant or breast-feeding, seek advice of a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right

away.

DIRECTIONS:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician

for use in children under 12 years of age.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to gingivitis, inflamed and bleeding gums and minor pain.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by

the Food and Drug Administration.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

NDC 43742-1509-1

HOMEOPATHIC

GUM

THERAPY

1 FL OZ (30 ml)

GUM THERAPY

calendula officinalis, kali phosphoricum, natrum muriaticum, arnica montana, agave americana, cistus canadensis,

kreosotum, myrrha, calcarea fluorica, aconitum napellus, bismuthum subnitricum, sepia, hepar sulphuris calcareum,

mercurius vivus liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:43742-150 9

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CALENDULA O FFICINALIS FLO WERING TO P (UNII: 18 E7415PXQ) (CALENDULA

OFFICINALIS FLOWERING TOP - UNII:18 E7415PXQ)

CALENDULA OFFICINALIS

FLOWERING TOP

1 [hp_X]

in 1 mL

DIBASIC PO TASSIUM PHO SPHATE (UNII: CI71S9 8 N1Z) (PHOSPHATE ION -

UNII:NK0 8 V8 K8 HR)

DIBASIC POTASSIUM

PHOSPHATE

3 [hp_X]

in 1 mL

3 [hp_X]

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

SODIUM CHLORIDE

3 [hp_X]

in 1 mL

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA - UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

6 [hp_X]

in 1 mL

AGAVE AMERICANA LEAF (UNII: 8 511ZMP5QK) (AGAVE AMERICANA LEAF -

UNII:8 511ZMP5QK)

AGAVE AMERICANA LEAF

6 [hp_X]

in 1 mL

HELIANTHEMUM CANADENSE (UNII: 46 G3W78 9 Q3) (HELIANTHEMUM CANADENSE -

UNII:46 G3W78 9 Q3)

HELIANTHEMUM

CANADENSE

6 [hp_X]

in 1 mL

WO O D CREO SO TE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)

WOOD CREOSOTE

6 [hp_X]

in 1 mL

MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L)

MYRRH

8 [hp_X]

in 1 mL

CALCIUM FLUO RIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

CALCIUM FLUORIDE

12 [hp_X]

in 1 mL

ACO NITUM NAPELLUS (UNII: U0 NQ8 555JD) (ACONITUM NAPELLUS -

UNII:U0 NQ8 555JD)

ACONITUM NAPELLUS

12 [hp_X]

in 1 mL

BISMUTH SUBNITRATE (UNII: H19 J0 6 4BA5) (BISMUTH CATION - UNII:ZS9 CD1I8 YE)

BISMUTH SUBNITRATE

12 [hp_X]

in 1 mL

SEPIA O FFICINALIS JUICE (UNII: QDL8 3WN8 C2) (SEPIA OFFICINALIS JUICE -

UNII:QDL8 3WN8 C2)

SEPIA OFFICINALIS JUICE

12 [hp_X]

in 1 mL

CALCIUM SULFIDE (UNII: 1MBW0 7J51Q) (CALCIUM SULFIDE - UNII:1MBW0 7J51Q)

CALCIUM SULFIDE

12 [hp_X]

in 1 mL

MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL)

MERCURY

12 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:43742-

150 9 -1

30 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /20 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 8 /20 /20 19

Labeler -

Deseret Biologicals (940741853)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(43742-150 9 ) , api manufacture(43742-150 9 ) , label(43742-150 9 ) , pack(43742-

150 9 )

Deseret Biologicals

Revised: 8/2019

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