NDC | 61383-701-01, 61383-701-96 |
Set ID | 53a1e60f-f641-4aed-874a-efcb13dc1074 |
Category | HUMAN OTC DRUG LABEL |
Packager | Dimensional Merchandising Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- Drug Facts
- Active Ingredients
- Purpose
- Uses:
-
Warnings:
For external use only.
Do Not Use: On wounds or damaged skin, with a heating pad, or on a child under 12 years of age with arthritis-like conditions.
Ask a Doctor Before Use If You Have: Redness over the affected area.
When Using This Product: Avoid contact with eyes or mucous membranes; do not bandage tightly.
Stop Use and Ask Doctor If: Condition worsens or symptoms persist for more than 7 days, if symptoms clear up and occur again within a few days, or if redness is present or excessive skin irritation develops.
CAUTION: Keep away from eyes. Wash hands and fingers thoroughly.
- Keep Out of Reach of Children:
-
Directions:
Use only as directed. After use, wipe off applicator head and replace protective cap. Clean outside with damp cloth or paper towel. Do not rinse under or immerse in water.
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: consult a doctor.
- STORAGE AND HANDLING
- Other Ingredients:
-
SPL UNCLASSIFIED SECTION
NatureWell™ CLINICAL
WITH KAVA EXTRACT
MUSCLE STRAINS
JOINT PAIN
STRAINS AND CRAMPS
TEMPORARY PAIN RELIEF • SOOTHES ACHES & PAINS • QUICK VANISHING ODOR
FAST-ACTING • NON-GREASY • QUICK-DRY FORMULA
HANDS FREE ROLLER BALL APPLICATION
MESS-FREE MASSAGING APPLICATOR
No Parabens • Dye-Free
Not Tested on Animals
Formula Made in the USA
Soothe aching muscles and joints with NatureWell™ Clinical
In an easy to use roll-on applicator, this product glides on for targeted, cooling relief. Formulated with 5% Menthol and 3.25% Eucalyptus Oil to reduce aches and pain. This no-mess, fast acting gel temporarily alleviates any aches or pains. Great for muscle strains, sprains and cramps.
BENEFITS
- FAST RELIEF
- SOOTHES ACHES AND PAINS
- QUICK VANISHING ODUR
- NO MESS APPLICATOR
KEY INGREDIENTS
- 5% Menthol - Helps relieve joint and muscle pain
- 3.25% Eucalyptus Oil - Helps relieve sore, stiff muscles
- Kava Extract - Helps provide additional cooling benefits
- Arnica & Calendula Extracts - Helps calm and comfort
DISTRIBUTED BY:
NATUREWELL™
PHOENIX, AZ 85016
- Packaging
-
INGREDIENTS AND APPEARANCE
MUSCLE AND JOINT PAIN RELIEF GEL
menthol, eucalyptus globulus leaf oil gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61383-701 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 5 g in 100 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 3.25 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) PIPER METHYSTICUM ROOT (UNII: BOW48C81XP) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 20 (UNII: 7T1F30V5YH) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61383-701-01 2 in 1 BLISTER PACK 11/16/2016 1 NDC:61383-701-96 96 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/16/2016 Labeler - Dimensional Merchandising Inc. (076693183) Establishment Name Address ID/FEI Business Operations Dimensional Merchandising Inc. 076693183 manufacture(61383-701)