Dermedial Anti-ouch Ointment
FDA Label NDC 70983-030

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Saje Natural Business Inc. for the product Dermedial Anti-ouch (NDC 70983-030). 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 other, drug facts active ingredient, otc - purpose, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS PACKAGE FOR FULL INFORMATION.

Distributed by: SAJE NATURAL WELLNESS 101-19347 24th Ave. Surrey, BC Canada V3S 3S9 | saje.com | 1-877-275-7253| Made by our friends in Canada

DO NOT USE IF SECURITY SEAL IS BROKEN OR MISSING.

SKU

Lift Here

Drug Facts Active Ingredient

Menthol 1.27%

Otc - Purpose

PurposeTopical Analgesic

UsesFor the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Warnings

For external use only.

Flammable: Keep away from fire or flame.

Do Not Use

  • on wounds or damaged skin
  • if allergic to plants of the asteraceae/compositae/daisy family.

When Using This Product

  • avoid contact with the eyes
  • do not bandage tightly

Stop Use And Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. 

If Pregnant Or Breast-Feeding,

ask a doctor before use.

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years of age and older: Apply to affected area 

Dosage & Administration

      not more than 3 times daily.

  • Not recommended for children under 12 years of age.

Inactive Ingredients

Arnica montana flower extract, beeswax (yellow), olive oil, and peppermint oil.

Questions?

1-877-275-7253

Disposal And Waste Handling

We support recycling.  Please recycle where possible. 

Saje® Natural Wellness Rescue Me - Nature's First Aid Kit With Dermedial Anti-Ouch+

Saje® Natural Wellness

Rescue Me - Nature's First Aid Kit

with

Dermedial Anti-Ouch+

Bump & Bruise Balm (Topical Analgesic)

net wt. 0.47 oz | 13.5 g

Tin (Trauma Less Ointment Box 60ml Final R1 01)

Tin (Trauma Less Ointment Box 60ml Final R1 01)

Retail Box (Rescuemekitpdp)

Retail Box (Rescuemekitpdp)

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