Active Ingredients
- Menthol 1.17%
- Oil of Turpentine 46.935%
Sloans
FDA Label NDC 60954-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pt. Eagle Indo Pharma for the product Sloans (NDC 60954-009). 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 active ingredients, purpose, uses, warnings, when using this product, stop use and ask doctor if, if pregnant or breastfeeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Uses
For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains
Warnings
For external use only
When Using This Product
- Avoid contact with eyes and mucous membranes when in use.
- Do not apply to wounds and damaged skin.
- Do not bandage tightly.
- Do not use otherwise than as directed.
Stop Use And Ask Doctor If
Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again, discontinue use of this product and consult a doctor.
If Pregnant Or Breastfeeding
Ask a health professional before use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact for Poison Control Centre right away.
Directions
- Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
- Children under 2 years of age: do not use, consult a doctor.
Other Information
Store below 86 oF (30 oC).
Inactive Ingredients
Camphor, D&C Red No.17, D&C Yellow No.11, Methyl Salicylate, Mineral Oil, Nonivamide, White Pine Oil
Questions?
If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.
Package Label
70ml NDC: 60954-009-70
70ml Unit Box (Sloan Ub 70ml V2)
* Please review the disclaimer below.
