REVALIFE- topical menthol ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

International Nutraceutical Company of America (INCA), LLC

INN (International Name):

MENTHOL

Composition:

MENTHOL 937.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose-Topical Analgesic Uses-Temporarily relieves minor pain of joints and muscles associated with arthritis, bursitis, tendonitis, strains

Authorization status:

OTC monograph not final

Summary of Product characteristics

REVALIFE- TOPICAL MENTHOL OINTMENT
INTERNATIONAL NUTRACEUTICAL COMPANY OF AMERICA (INCA), LLC
_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._
----------
DRUG FACTS
Active Ingredient : Menthol 3%
Purpose-Topical Analgesic
Uses-Temporarily relieves minor pain of joints and muscles associated
with arthritis, bursitis,
tendonitis, strains
Directions: Apply to clean, dry skin over painful joint or muscle
gently massaging until cream
disappears. For optimum results use daily for 30 days and continue to
use daily thereafter. Repeat as
neccessary. Close cap tightly after use.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right
away.
For external use only. Do not bandage tightly or use with a heating
pad. Avoid contact with mouth,
eyes, and mucous membranes. Do not apply to wounds, damaged, broken,
or irritated skin.
Stop use and ask a doctor if: Symptoms persists over 7 day or clear up
and occur again within a few
days. Redness is present or irritation develops. Using on a child 12
years of age or under.
Inactive Ingredients: EDTA, Ethanol, Isopropyl palmitate, Methyl
Paraben, Monosodium Phosphate, N-
Acetyl Glucosamine, Poloxamer 407, Propyl Paraben, Soy Lecithin,
Todopherol Acetate (Vitamin E),
Water
IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE
REVALIFE
topical menthol ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:42452-378
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
9 37.5 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)
ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)
LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)
ALCO HO L (UNII: 3K9 9 58 V9 0 M)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
PRO P