Acne HP: Homeopathic Product Information

ACNE HP- carbo animalis, activated charcoal, potassium dichromate, sodium chloride, pulsatilla vulgaris, sepia officinalis juice, silicon dioxide, sulfur and zinc liquid
BioActive Nutritional, Inc.

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.

ACTIVE INGREDIENTS:

Carbo Animalis 30X, Carbo Vegetabilis 30X, Kali Bichromicum 30X, Natrum Muriaticum 30X, Pulsatilla (Vulgaris) 30X, Sepia 30X, Silicea 30X, Sulphur 30X, Zincum Metallicum 30X.

INDICATIONS:

For temporary relief of eruptions due to acne.

WARNINGS:

If pregnant or breast-feeding , ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of eruptions due to acne.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIO Active Nutritional

ACNE-HP

HOMEOPATHIC

1 FL OZ (30 ml)

ACNE HP carbo animalis, carbo vegetabilis, kali bichromicum, natrum muriaticum, pulsatilla (vulgaris), sepia, silicea, sulphur, zincum metallicum liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0275 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBO ANIMALIS (CARBO ANIMALIS) CARBO ANIMALIS 30 [hp_X] in 1 mL ACTIVATED CHARCOAL (ACTIVATED CHARCOAL) ACTIVATED CHARCOAL 30 [hp_X] in 1 mL POTASSIUM DICHROMATE (DICHROMATE ION) POTASSIUM DICHROMATE 30 [hp_X] in 1 mL SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 30 [hp_X] in 1 mL PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS 30 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 30 [hp_X] in 1 mL SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 30 [hp_X] in 1 mL SULFUR (SULFUR) SULFUR 30 [hp_X] in 1 mL ZINC (ZINC) ZINC 30 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43857-0275-1 30 mL in 1 BOTTLE, DROPPER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/04/2014

Labeler — BioActive Nutritional, Inc. (624980496)

Registrant — Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture (43857-0275), api manufacture (43857-0275), label (43857-0275), pack (43857-0275)

Revised: 06/2017 BioActive Nutritional, Inc.