Extra Strength Balm CAPSICUM AND MENTHOL SAJE NATURAL BUSINESS INC FDA Approved Extra Strength Balm Warming pain relief ointment 0.9 fl oz (25 g)

EXTRA STRENGTH BALM

Generic: CAPSICUM AND MENTHOL
Mfr: SAJE NATURAL BUSINESS INC FDA OTC
FunFoxMeds box
Substance Capsicum
Route
TOPICAL
Applications
M017
Product NDC
70983-0027-00 70983-0027-01
Package NDC
70983-027-01

Drug Facts

Composition & Profile

Active Ingredients
Capsicum (from Capsicum Frutescens fruit extract) 5% Menthol 2.5%
Inactive Ingredients
Beeswax butyrospermum parkii (shea) butter calendula officinalis flower extract capryloyl glycerin cinnamomum zeylanicum (cinnamon) leaf oil cocos nucifera (coconut) oil diheptyl succinate elettaria cardamomum (cardamom) seed oil eugenia caryophyllus (clove) bud oil glycine soja (soybean) oil olea europaea (olive) fruit oil prunus amygdalus dulcis (sweet almond) oil rosmarinus officinalis (rosemary) extract rosmarinus officinalis (rosemary) leaf oil rubus idaeus (raspberry) seed oil sebacic acid copolymer simmondsia chinensis (jojoba) seed oil squalane theobroma cacao (cocoa) seed butter tocopherol zingiber officinale (ginger) root oil
Strengths
5 % 2.5 %
Treats Conditions
For The Temporary Relief Of Minor Aches And Pains Of Muscles And Joints Associated With Simple Backache Arthritis Strains Bruises Sprains Provides Warming Pain Relief

Identifiers & Packaging

Container Type UNKNOWN
NDC 70983-0027-00
All Product Codes
70983-0027-00 70983-0027-01
UNII
00UK7646FG L7T10EIP3A
SPL Set IDs
f516e416-446b-8f21-e053-2a95a90afd88
Packaging

Extra Strength Balm - outer label Extra Strength Balm - outer label

Package Descriptions
  • Extra Strength Balm - outer label Extra Strength Balm - outer label
Overview

Extra Strength Balm Warming pain relief ointment 0.9 fl oz (25 g)

Indications & Usage

For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains. Provides warming pain relief.

Dosage & Administration

Adults: Apply a thin layer to affected area not more than 3-4 times daily, massaging well into skin. Wash hands well after use. Patch test recommended prior to use. Spatula recommended to reduce contact with the product. Do not inhale directly–keep lid on product when not in use.

Warnings & Precautions
For external use only.
Purpose

External analgesic (counterirritant)

Do Not Use

Do not apply to • wounds • damaged skin • bandage tightly • with external heat. This may result in skin irritation or skin burn.

When Using

Avoid contact with the eyes.

Stop Use & Ask a Doctor

Stop use and ask a doctor if • condition worsens, • if symptoms persist for more than 7 days • clear up and reoccur within a few days.

Storage & Handling

Store in a cool, dark place.

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Additional Information

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