Pain Relieving Cream
FDA Label NDC 85063-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mediapower, Inc. Dba Dr Newton's And Naturals for the product Pain Relieving Cream (NDC 85063-101). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Histamine dihydrochloride 0.05% w/w
Purpose
Pain reliever
Uses
for the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains
Warnings
For external use only
Do not use • on wounds or damaged skin • if you are allergic to ingredients in this product
When using this product • avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water • do not bandage tightly or use a heating pad
Stop use and ask a doctor if • rash appears • condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If 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 not more than 3 to 4 times daily • children under 12 years of age: do not use, consult a physician
Other Information
store between 68° and 77° F (20° and 25° C)
Inactive Ingredients:
Water, Cetearyl alcohol, Emu oil, Glycerin, Ceteareth-20, Glucosamine sulfate, Dimethyl sulfone, Caprylic/capric triglyceride, Phenoxyethanol, Cetyl alcohol, Tocopherol acetate, Butylene glycol, Propylene glycol, Chamomile (Chamomilla recutita) flower extract, Rosemary (Rosemarinusofficinalis) leaf extract, Indian frankincense (Boswellia serrata) extract, Ethylhexylglycerin.
Questions Or Comments?
+1-866-788-5951
You may also report serious side effects to this phone number.
Mon-Fri 8:00 A.M. - 6:00 P.M.
Packaging
Painrelieving1 (85063101 1)
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