REACTICE REACTIVATING ICE BAUME- menthol cream

Reactice by

Drug Labeling and Warnings

Reactice by is a Otc medication manufactured, distributed, or labeled by Rejuventus, Inc., Rwm Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients              Purpose

Menthol (5%)                   External Analgesic        

Uses

For temporary relief of minor aches and pains of muscles such as: simple backache, lumbago, arthritis, neuralgia, strains, bruises, strains, bruises,  and sprains

Keep out of reach of children

Consult a doctor and discontinue use if conditions worsen or persist for more than 7 days.

For External use only. When using this product avoid contact with eyes. Wash hands completely after each use. If swallowed seek medical assistance immediately or contact poison control. If you are pregnant or nursing,seek the advice of your doctor before using this product.

Directions for use

Apply cream to sore muscles and joints and massage into skin as needed. For 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 consult a doctor.

Water, Dimethyl Sulfone, Clove bud oil, Peppermint oil, Eucalyptus oil, Aloe Vera, Ascorbic acid, Tocopherol, Glycine, Wintergreen oil, Jojoba oil, Arnica Montana  Flower Extract, Polyacrylamide, C13-14 Isoparaffin, Laureth 7, Sodium Hydroxymethylglycinate, glycerol.

PRINCIPAL DISPLAY PANEL

Reactice

Reactivating Ice Baume

external analgesic

16 fl oz./473ml

INGREDIENTS AND APPEARANCE

REACTICE  REACTIVATING ICE BAUME
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75963-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	118.29 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CLOVE (UNII: K48IKT5321)
PEPPERMINT OIL (UNII: AV092KU4JH)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCINE (UNII: TE7660XO1C)
JOJOBA OIL (UNII: 724GKU717M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75963-125-01	118.29 mL in 1 JAR
2	NDC: 75963-125-02	473 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/21/2011

Labeler - Rejuventus, Inc. (032186703)

Registrant - Rejuventus, Inc. (032186703)

Establishment
Name	Address	ID/FEI	Business Operations
Rwm Technologies		003215779	manufacture