FDA.reportPublic FDA data

ACNE HP

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2022-02-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:16:23

Label at a glance#

ProductACNE HP
Active ingredientCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS WHOLE, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Carbo Animalis 30X, Carbo Vegetabilis 30X, Kali Bichromicum 30X, Natrum Muriaticum 30X, Pulsatilla 30X, Sepia 30X, Silicea 30X, Sulphur 30X, Zincum Metallicum 30X.

OTC - PURPOSE SECTION

USES: Temporarily relieves eruptions, rashes, itchy skin &/or other symptoms related to acne.**

INDICATIONS & USAGE SECTION

USES: Temporarily relieves eruptions, rashes, itchy skin &/or other symptoms related to acne.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years, 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACATIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

OTC - QUESTIONS SECTION

Questions & Comments?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

*The letters "HPUS" indicate 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

43406-0001-1

ACNE HP

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

 UPC: 877730000415

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0001-12022-02-14C16284748780-1d6a99b39-6c2a-a426-e053-dadaa90af4c2ACNE HP
43406-0001-12022-01-28C16284748780-1d6a99b39-6c2a-a426-e053-dadaa90af4c2ACNE HP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0001-1ACNE HP30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0001ACNE HP (CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC) LIQUID [NATURAL CREATIONS, INC.]4Current NDC, Legacy NDC, 1 package rows20220215_b2368ab6-e233-4473-99fa-86e1fbc2a879.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACTIVATED CHARCOALACTIVE INGREDIENT2P3VWU3H101
CARBO ANIMALISACTIVE INGREDIENT279O8I04331
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FM1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
SULFURACTIVE INGREDIENT70FD1KFU701
ZINCACTIVE INGREDIENTJ41CSQ7QDS1
ACTIVATED CHARCOALACTIVE MOIETY2P3VWU3H101
CARBO ANIMALISACTIVE MOIETY279O8I04331
DICHROMATE IONACTIVE MOIETY9LKY4BFN2V1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
SULFURACTIVE MOIETY70FD1KFU701
ZINCACTIVE MOIETYJ41CSQ7QDS1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-000143406-0001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBO ANIMALIS279O8I0433ACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SULFUR70FD1KFU70ACTIB
ZINCJ41CSQ7QDSACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
ndc (package): 43406-0001-1
ndc (product): 43406-0001
ndc11 (package): 43406000101
spl id: 590b80f7-4981-401e-b093-31510ac26afe
spl set id: b2368ab6-e233-4473-99fa-86e1fbc2a879

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.