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  5. Label Information: Soothe And Move Pain Relief Cream

FDA Label for Soothe And Move Pain Relief Cream

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. OTHER SAFETY INFORMATION
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PACKAGE LABELING - PRINCIPAL DISPLAY PANEL

Soothe And Move Pain Relief Cream Product Label

The following document was submitted to the FDA by the labeler of this product Simtec Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



DRUG FACTS


Otc - Active Ingredient



Active Ingredients
Camphor 3.18%


Otc - Purpose



Purpose
Topical Analgesic


Indications & Usage



Uses:
Temporarily relieves the minor aches
and pains of joints and muscles
associated with simple backache,
arthritis, strains, bruises, sprains.


Warnings



Warnings:
For External Use Only


Otc - Do Not Use



Do not use:
■ Other than as directed
■ 0n wounds or damaged
   skin
■ With a heating pad
■ If you are allergic to any
   ingredient in this product
■ 0n a child under 12 with
   arthritis-like conditions


Otc - When Using



When using this product:
■ Avoid contact with eyes, wounds,
mucus membrane, irritated skin.
■ Do not bandage tightly.


Otc - Stop Use



Stop use and ask a doctor if:
■Condition worsens, if symptoms
persist for more than 7 days or clear up
and occur again within a few days.
■Skin redness or excessive irritation of
the skin develops.


Otc - Pregnancy Or Breast Feeding



■ If pregnant or breastfeedlng, ask a
doctor before use.


Otc - Keep Out Of Reach Of Children



Keep out ofthe reach of
chilaren:
If swallowed, get medical help or
contact a Poison Control Center
immediately


Dosage & Administration



Directions:
■ Adults and children 12 years of age
and older: apply to affected area not
more than 3 to 4 times dally.
■ Children under 12 years of age:
ask a doctor


Other Safety Information



Other Information:
Store in a cool dry place 68 - 77 F
(20 - 25 C) Minor separation may
occur. Shake well before using.


Inactive Ingredient



Inactive Ingredients:
Acrylamide/Sodium Acryloyldimethyl
Taurate Copolymer, Aloe Barbadensis
Leaf Juice, Arnica Oil, Behentrimonium
Methosulfate, Caprylic/Capric
Triglyceride, Capryly1 Glycol, Cetearyl
Alcohol, Cetyl Alcohol, Cholecalciferol,
Chondroitin Sulfate, Coenzyme
Q 10, Corn Oil, Deionized Water, Emu
Oil, Glucosamine Sulfate, Glycerin,
Green (Camellia Sinensis) Tea Extract,
Isohexadecane, Peppermint Oil*,
Phenoxyethanol, Polysorbate 80, SO
Alcohol, Shark cartilage, Shea Butter,
Sorbic Acid, Tetrahexyldecyl
Ascorbate, Tocopheryl Acetate,
Yucca (Glauca) Root Extract.
*A source of natural menthol.


Otc - Questions



Ouestlons?
Call 1-855-223-6010
Weekdays between 9am to 5pm CST


Package Labeling - Principal Display Panel



SOOTHE & MOVE
PAIN RELIEF CREAM

soothing relief that keeps you moving

Doctor Formulated & Recommended

• Fast Acting Topical
• Deep Penetrating
• No Greasy Residue

ALL33
Net Wt. 2.75 Oz
(77.96 g)
Vitamin C, D, E • Botanicals • Antioxidants

Shake before use

Ouestlons?
call 1-855-223-6010
Weekdays betwean 9am to 5pm CST
Distributed by Simtec, LLC.
Beverly Hills, CA

Soothe&Move - Soothe Move

Soothe&Move - Soothe Move

RES


* Please review the disclaimer below.