Bactoflam

Bactoflam
SPL v2
SPL
SPL Set ID b965fbd3-050d-4073-ab32-f67f0c5335f4
Route
ORAL
Published
Effective Date 2021-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Apis Mellifera (12 [hp_X]) Arsenic Cation (3+) (3 [hp_X]) Baptisia Tinctoria Root Atropa Belladonna Echinacea, Unspecified Ferrosoferric Phosphate Toxicodendron Pubescens Leaf
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-06-01

Description

ACTIVE INGREDIENTS (HPUS*): 100 mL contains 14.28 mL each: Apis mel 12X, Arsenicum alb 12X, Baptisia 3X, Belladonna 12X, Echinacea 3X, Ferrum phos 12X, Rhus tox 12X. *The letters “HPUS” indicate that the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Warnings and Precautions

WARNINGS:

Stop use and call a doctor if symptoms persist or worsen.

If pregnant or breast-feeding, consult a healthcare professional before use.

Keep out of reach of children.

Contains alcohol: in case of accidental overdose, consult a poison control center

immediately.

Indications and Usage

INDICATIONS: For the temporary relief of heat, redness, swelling due to inflammation. (**)

Dosage and Administration

DIRECTIONS: Take 6 drops orally 4 times a day. For ages 2 to adult.

Description

ACTIVE INGREDIENTS (HPUS*): 100 mL contains 14.28 mL each: Apis mel 12X, Arsenicum alb 12X, Baptisia 3X, Belladonna 12X, Echinacea 3X, Ferrum phos 12X, Rhus tox 12X. *The letters “HPUS” indicate that the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1
  • Keep out of reach of children.
Section 51727-6

INACTIVE INGREDIENTS: Ethanol (20% v/v), Purified water.

Section 51945-4

NDC 73421-0052-1

MICRO-WEST

Homeopathic

BACTOFLAM

Product #: 0052

1.0 fl oz (29.6 mL)

Ethanol 20%

Section 53413-1

Manufactured for:

MICRO-WEST

PO Box 950

Douglas, WY 82633

(307) 358-5066

Section 55105-1

For the temporary relief of heat, redness, swelling due to inflammation.

Section 55106-9

ACTIVE INGREDIENTS (HPUS*): 100 mL contains 14.28 mL each: Apis mel 12X, Arsenicum alb 12X, Baptisia 3X,

Belladonna 12X, Echinacea 3X, Ferrum phos 12X, Rhus tox 12X.

*The letters “HPUS” indicate that the components in the product are officially monographed in the Homeopathic Pharmacopeia of the

United States

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 60561-8

OTHER INFORMATION: Tamper resistant for your protection. Use only if safety seal is intact.


Structured Label Content

Indications and Usage (34067-9)

INDICATIONS: For the temporary relief of heat, redness, swelling due to inflammation. (**)

Dosage and Administration (34068-7)

DIRECTIONS: Take 6 drops orally 4 times a day. For ages 2 to adult.

Warnings and Precautions (34071-1)

WARNINGS:

Stop use and call a doctor if symptoms persist or worsen.

If pregnant or breast-feeding, consult a healthcare professional before use.

Keep out of reach of children.

Contains alcohol: in case of accidental overdose, consult a poison control center

immediately.

Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Ethanol (20% v/v), Purified water.

Section 51945-4 (51945-4)

NDC 73421-0052-1

MICRO-WEST

Homeopathic

BACTOFLAM

Product #: 0052

1.0 fl oz (29.6 mL)

Ethanol 20%

Section 53413-1 (53413-1)

Manufactured for:

MICRO-WEST

PO Box 950

Douglas, WY 82633

(307) 358-5066

Section 55105-1 (55105-1)

For the temporary relief of heat, redness, swelling due to inflammation.

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS (HPUS*): 100 mL contains 14.28 mL each: Apis mel 12X, Arsenicum alb 12X, Baptisia 3X,

Belladonna 12X, Echinacea 3X, Ferrum phos 12X, Rhus tox 12X.

*The letters “HPUS” indicate that the components in the product are officially monographed in the Homeopathic Pharmacopeia of the

United States

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 60561-8 (60561-8)

OTHER INFORMATION: Tamper resistant for your protection. Use only if safety seal is intact.


Advanced Ingredient Data


Raw Label Data

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