Label: PAIN RELIEF BALMPREFERRED PLUS PH PREFERRED PLUS PHARMACY- menthol and methyl salicylate gel
- NDC Code(s): 61715-020-92
- Packager: Kinray Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- ACTIVE INGREDIENT
Methyl Salicylate 29.0%Close
- INDICATIONS & USAGE
Temporarily relieves minor pain associated with: arthritis, simple backache, muscle strains, bruises, sprains and cramps.Close
For external use only. Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product: use only as directed, avoid contact with the eyes or mucus membranes, do not bandage tightly or use with a heating pad, do not apply to wounds or damaged skin. Stop use and ask doctor if: condition gets worse, symptoms last more than 7 days, or symptoms clear up and occur again in a few days. If pregnant or breast-feeding: ask a healthcare professional before use.Close
- DOSAGE & ADMINISTRATION
Adults and children 12 years of age and older: apply generously to affected area. Massage into painful are until thoroughly absorbed into skin. Repeat as necessary, but not more than 4 times daily. Children under 12 years of age: ask doctor.Close
- INACTIVE INGREDIENT
Paraffin, White Petrolatum.Close
Pain relieving gel.
- 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.Close
- PRINCIPAL DISPLAY PANEL
Preferred Plus Pharmacy Cool 'N Heat Therapy Pain Relief Balm
- INGREDIENTS AND APPEARANCE
PAIN RELIEF BALMPREFERRED PLUS PH PREFERRED PLUS PHARMACY
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-020 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .076 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE .29 g in 100 g Inactive Ingredients Ingredient Name Strength PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-020-92 99.2 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/15/2013 Labeler - Kinray Inc. (012574513)