Otc - Active Ingredient
ACTIVE INGREDIENTS: alendula officinalis 12C HPUS, Nux vomica 12C HPUS, Silicea 12C HPUS.
H Acne Formula Oil
FDA Label NDC 57520-1111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product H Acne Formula (NDC 57520-1111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
INDICATIONS: For the temporary relief of the symptoms of acne, blemishes and pimples.
Warnings
WARNINGS: For external use only.
Perform skin test prior to initial use.
Do not use if pregnant or breastfeeding.
Keep out of reach of children. Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control Center right away.
Discontinue use if irritations occurs.
Consult a doctor if symptoms worsen after 7 days.
Dosage & Administration
DIRECTIONS: Adults and Children 4 yrs and over: Wash hands before and after use. Shake well and apply 1 or 2 drops to a cotton swab or your finger and apply directly to the affected area 3x per day. Do not oversaturate or exceed dosage.
Inactive Ingredient
INACTIVE INGREDIENTS: Cymbopogon martinii aerial parts, Daucus carota seed, Helichrysum italicum flower, Lavandula officinalis flower bud, Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole plant, Ethanol.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control Center right away.
Indications & Usage
INDICATIONS: For the temporary relief of the symptoms of acne, blemishes and pimples.
Otc - Questions
Dist. by Healing Natural Oils
1042 N El Camino Real #B-426
Encinitas, CA 92024 USA
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Package Label.Principal Display Panel
Healing Natural Oils
H Acne Formula
Homeopathic
For External Use Only
045
33ml (1.12 fl. oz)
H-acne Formula (Mm1)
* Please review the disclaimer below.
