MAXXIMA- camphor and menthol lotion

Maxxima by

Drug Labeling and Warnings

Maxxima by is a Otc medication manufactured, distributed, or labeled by Dr. Knoll Products, Inc., Vita-Herb Nutriceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Camphor 3.01%

Menthol 1.25%

PURPOSE

Purpose

Topical analgesic

Topical analgesic

INDICATIONS & USAGE

Usesfor temporary relief of minor aches and pains of muscles and joints associated with

• simple backache
• arthritis
• strains
• sprains
• bruises
  

WARNINGS

Warnings

For external use only

Do not use

• on children under 10 years of age
• on wounds or damaged skin
  

When using this product

• use only as directed
• do not bandage tightly
• avoid contact with eyes and open sores
  

Stop use and ask doctor if

• excessive redness or skin irritation is present
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  

If pregnant or breastfeeding, ask a health professional before use.

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.

STORAGE AND HANDLING

Other Information

store between 15 degrees and 30 degrees C (59 degrees to 86 degrees F)

DOSAGE & ADMINISTRATION

Directions

• Shake well before use
• Adults and children 10 years of age and older:
• • apply to affected area not more than 3-4 times daily
  • massage lightly into painful areas until thoroughly absorbed into the skin
• Children under 10 years of age consult a physician
  

INACTIVE INGREDIENT

Inactive ingredients

glycerin, water, hydroxypropylmethylcellulose, propylene glycol, aloe vera extract, lavender oil, tea tree oil, spruce oil, rosemary oil, sage oil, juniper berry oil, cajeput oil, peppermint oil, horse chestnut extract, methyl paraben, sodium copper chlorophyllin, propyl paraben

QUESTIONS

Manufactured for: Dr. Knoll Products, Inc.

374 Newton Street, P.O. Box 116, Canfield, OH 44406

TO REORDER: 1-800-2434

PRINCIPAL DISPLAY PANEL

Maxxima 

The Pain Relieving Cream

External Analgesic

with Camphor and Menthol

With Moisturizing Aloe

 fl oz ( ml)

For your protection, this bottle has an imprinted seal around the neck. 

INGREDIENTS AND APPEARANCE

MAXXIMA 
camphor and menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50638-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.01 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYPROMELLOSES (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
PICEA MARIANA LEAF OIL (UNII: Q1J49L1A5O)
ROSEMARY OIL (UNII: 8LGU7VM393)
SAGE OIL (UNII: U27K0H1H2O)
JUNIPER BERRY OIL (UNII: SZH16H44UY)
CAJUPUT OIL (UNII: J3TO6BUQ37)
PEPPERMINT OIL (UNII: AV092KU4JH)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50638-100-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2012
2	NDC: 50638-100-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/11/2012

Labeler - Dr. Knoll Products, Inc. (121880975)

Establishment
Name	Address	ID/FEI	Business Operations
Vita-Herb Nutriceuticals, Inc.		053760034	manufacture(50638-100)