CML by Primary Pharmaceuticals, Inc. / Terrain Pharmaceuticals CML Patch
CML by
Drug Labeling and Warnings
CML by is a Otc medication manufactured, distributed, or labeled by Primary Pharmaceuticals, Inc., Terrain Pharmaceuticals. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
CML- camphor, lidocaine, and methyl salicylate patch
Primary Pharmaceuticals, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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CML Patch
Uses
Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:
muscle soreness
strains
sprains
arthritis
simple backache
muscle stiffness
bruises
Warnings
For external use only
Stomach bleeding warning
This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you
are age 60 or older
have had stomach ulcers or bleeding problems
take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others)
take a blood thinning (anticoagulant) or steroid drug
have three or more alcoholic drinks every day while using this product
take more or for a longer time than directed
Do not use
on the face or rashes; on wounds or damaged skin
in the eyes, mouth, or other mucous membranes
on genitals
with a heating pad
if allergic to any NSAIDS
right before or after heart surgery
any patch from a pouch that has been opened for 7 or more days
Ask a doctor before use if
you are allergic to topical products
the stomach bleeding warning applies to you
you are taking a diuretic
you have high blood pressure, heart disease, or kidney disease
you are pregnant
When using this product
wash hands after applying or removing patch
avoid contact with eyes. If eye contact occurs, rinse thoroughly with water
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
Stop use and consult your physician if
stomach pain or upset gets worse or lasts
rash, irritation, or itching develops
you feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding)
condition worsens
Directions
Adults, or children over the age of 12:
Apply patch to affected area 1 to 2 times daily or as directed.
Instructions for Use
clean and dry affected area
open pouch and remove one patch
remove protective film from patch
apply one patch to the affected area of pain and leave in place for 8 to 12 hours
if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
only use one patch at a time
do not use more than 2 patches per day
wash hands with soap and water after applying or removing patch
reseal pouch containing unused patches immediately after each use
Children under 12 years of age: Do not use
Other Information
some individuals may not experience pain relief until several minutes or hours after applying the patch
store in a cool, dry place
protect product from excessive moisture or sunlight
store at 67-77°F (19-25°C)
Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxynol-30, Polyacrylic Acid, Polysorbate 80, Sodium Polyacrylate, Sorbitan Sesquioleate, Starch, Talc, Tartaric Acid, Titanium Dioxide, Water
| CML
camphor, lidocaine, and methyl salicylate patch |
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| Labeler - Primary Pharmaceuticals, Inc. (066126126) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Terrain Pharmaceuticals | 078358750 | manufacture(72275-006) | |