Otc - Active Ingredient
Camphor 1%
Pain Relief Cream
FDA Label NDC 70576-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Health Town Inc for the product Pain Relief Cream (NDC 70576-001). 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 otc - active ingredient, otc - purpose, indications & usage, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, pain relief cream, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External Analgesic
Topical Analgesic
Pain relieving cream
Indications & Usage
Temporarily relieves minor aches and pains of muscles and joints associate with:
-simple backache
-arthritis
-strains
-bruises
-spains
Otc - Keep Out Of Reach Of Children
Children under 2 years of age: consult a doctor.
Warnings
For extenal use only
Do not use:
-on wounds
-on irritated or damaged skin
-otherwise than as directed
When using this product:
-avoid contact with the eyes or mucous membranes
-do not bandage tightly
Dosage & Administration
-adults and children 3 years of age and older: apply 3 or 4 drops of medicate oil to the affecte area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and ten massaged as shown in the illustrations.
-Children under 3 years of age, consult your physician
-refer to the above warning; otherwise than as directed may be dangerous
Inactive Ingredient
Yellow Vaseline
Wool Grease
Liquid Paraffin
Stearic Acid
Glycerol
Triethanolamine
Ethylparaben
Dimethyl Sulfoxide
Radix Illcis Pubescentis
Cortex Araliae
Pheretima
Herba Hedyotis Chrysotricae
Radix Pini Massonianae
Sophorae Flavescentis Radix
Drynariae Rhizoma
Radix Adinae Rubellae
Radix Cudraniae Cochinchinensis
Root from Itea Oblonga Hand.-Mazz
Root from Syzygium Grijsii (Hance) Merr. Et
Perry & Root from Ampelopsis Sinica (Miq) W.T. Wang & Root from Ormosia Henryi Prain & Cuscuta Japonica Choisy
Pain Relief Cream
Pain Relief Cream (2nd Revised Label)
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