GUM THERAPY- calendula officinalis, eugenia caryophyllata, plantago major, phytolacca decandra, arnica montana, phosphorus, pept

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), CLOVE (UNII: K48IKT5321) (CLOVE - UNII:K48IKT5321), PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U), PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG), ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW), PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W), PEPTOSTREPTOCOCCUS ANAEROBIUS (UNII: YQI5QWB9DU) (PEPT
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, pyorrhea, minor pain and ulcerations.** **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, pyorrhea, minor pain and ulcerations.** **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:
43742-0085-1

GUM THERAPY- calendula officinalis, eugenia caryophyllata, plantago major, phytolacca

decandra, arnica montana, phosphorus, peptostreptococcus, carbo vegetabilis, hepar sulphuris

calcareum, lachesis mutus, mercurius solubilis 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, Eugenia Caryophyllata 1X, Plantago Major 1X, Phytolacca Decandra 2X,

Arnica Montana 3X, Phosphorus 12X, Peptostreptococcus 15X, 30X, Carbo Vegetabilis 30C, Hepar

Sulphuris Calcareum 30C, Lachesis Mutus 30C, Mercurius Solubilis 30C.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to gingivitis, inflamed and bleeding gums, pyorrhea, minor

pain and ulcerations.**

**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

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.

INACTIVE INGREDIENTS:

Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN:

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

away.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to gingivitis, inflamed and bleeding gums, pyorrhea, minor

pain and ulcerations.**

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

the Food and Drug Administration.

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

NDC 43742-0085-1

HOMEOPATHIC

GUM

THERAPY

1 FL OZ (30 ml)

GUM THERAPY

calendula officinalis, eugenia caryophyllata, plantago major, phytolacca decandra, arnica montana, phosphorus,

peptostreptococcus, carbo vegetabilis, hepar sulphuris calcareum, lachesis mutus, mercurius solubilis liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:43742-0 0 8 5

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

CLO VE (UNII: K48 IKT5321) (CLOVE - UNII:K48 IKT5321)

CLOVE

1 [hp_X]

Deseret Biologicals

CLO VE (UNII: K48 IKT5321) (CLOVE - UNII:K48 IKT5321)

CLOVE

in 1 mL

PLANTAGO MAJO R (UNII: W246 9 WNO6 U) (PLANTAGO MAJOR - UNII:W246 9 WNO6 U)

PLANTAGO MAJOR

1 [hp_X]

in 1 mL

PHYTO LACCA AMERICANA RO O T (UNII: 11E6 VI8 VEG) (PHYTOLACCA AMERICANA

ROOT - UNII:11E6 VI8 VEG)

PHYTOLACCA AMERICANA

ROOT

2 [hp_X]

in 1 mL

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

ARNICA MONTANA

3 [hp_X]

in 1 mL

PHO SPHO RUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)

PHOSPHORUS

12 [hp_X]

in 1 mL

PEPTO STREPTO CO CCUS ANAERO BIUS (UNII: YQI5QWB9 DU)

(PEPTOSTREPTOCOCCUS ANAEROBIUS - UNII:YQI5QWB9 DU)

PEPTOSTREPTOCOCCUS

ANAEROBIUS

15 [hp_X]

in 1 mL

ACTIVATED CHARCO AL (UNII: 2P3VWU3H10 ) (ACTIVATED CHARCOAL -

UNII:2P3VWU3H10 )

ACTIVATED CHARCOAL

30 [hp_C]

in 1 mL

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

CALCIUM SULFIDE

30 [hp_C]

in 1 mL

LACHESIS MUTA VENO M (UNII: VSW71SS0 7I) (LACHESIS MUTA VENOM -

UNII:VSW71SS0 7I)

LACHESIS MUTA VENOM

30 [hp_C]

in 1 mL

MERCURIUS SO LUBILIS (UNII: 324Y40 38 G2) (MERCURIUS SOLUBILIS -

UNII:324Y40 38 G2)

MERCURIUS SOLUBILIS

30 [hp_C]

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-

0 0 8 5-1

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

Pro duc t

0 3/29 /20 16

0 4/21/20 21

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 /0 3/20 12

0 4/21/20 21

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(43742-0 0 8 5) , api manufacture(43742-0 0 8 5) , label(43742-0 0 8 5) , pack(43742-

0 0 8 5)

Revised: 12/2016

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