Ouch Aid
FDA Label NDC 51979-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Hauschka Skincare Inc. for the product Ouch Aid (NDC 51979-001). 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, inactive ingredient, otc - purpose, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, otc - ask doctor, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Inactive Ingredient

→ Otc - Purpose

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Ask Doctor

→ Indications & Usage

→ Dosage & Administration

→ Description

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredient: Arnica montana

Inactive Ingredient

Inactive Ingredients: Alcohol, Purified Water

Otc - Purpose

first aid for sprains, strains and bruises

Warnings

Contains 25% alcohol by volume. Do not apply to broken skin. Avoid mucous membranes and the area around the eyes. Wash your hands thoroughly after use. Do not use if you are allergic to plants in the daisy family (Compositae).

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding

Do not apply to nipples if you are nursing. Do not use during pregnancy.

Otc - Ask Doctor

If symptoms do not improve within 3-4 days, consult a doctor.

Indications & Usage

Uses: For temporary relief of pain and swelling associated with sprains, strains, bruises and general muscular discomfort.

Dosage & Administration

Directions: Apply topically to affected area as a compress. See insert for further information. Follow with Dr. Hauschka Arnica Bump and Bruise Relief.