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DRUG FACTS
Soothe And Move Pain Relief Cream
FDA Label NDC 78805-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Simtec Llc for the product Soothe And Move Pain Relief Cream (NDC 78805-005). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
RES
* Please review the disclaimer below.
