DREAM CREAM- camphor, menthol cream

Dream Cream by

Drug Labeling and Warnings

Dream Cream by is a Otc medication manufactured, distributed, or labeled by Little Moon Essentials, Little Moon Essentials LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Camphor 0.45%

Menthol 5%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with

• Simple backache
• Muscle strains
• Strains
• Bruises

Warnings

For external using this product

• ​Use only as irected
• ​Read and follow all directions and warningson this label
• ​Rare cases of serious burns have been reported with products of this type
• ​Do not bandage tightly or apply local heat (such as heating pads) or medicated patches to the area of use
• Avoid contact with eyes and mucous membranes
• Do not aply to wounds or damaged, broken irritated skin
• A trasient burning sensation may occur upon application but generally dissapears in several days

Stop use and ask a doctor

• ​Condition worsens
• Redness is present
• Irritation develops
• Symptoms persist for more than 7 days or clear up and occur again within a few days
• You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast feeding ​

Ask a health professional before use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

• Apply a thin layer to affected area
• ​Massage into painful aea until thoroughly absorbed into skin repeat as necessary, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications
  • ​ AFTER APPLYING, WASH HANDS WITH SOAP AND WATER​

  ​​Children 12 years or younger: ask a doctor

Other information

• Store at 68-77ºF (20-25ºC)
• ​Protect from excessive moisture

Inactive Ingredients

Water (aqua)

Organic safflower oil (cathamus tinctorius)

Beeswax (cera alba)

Cetearyl olivate

Arnica oil (arnica montana)

Castor oil (ricinus communis)

Cetearyl alcohol

Wintergreen oil (gaultheria procumbens)

Xanthan gum

Cinnamom oil (Cinnamomum zeylanicum)

Lavender oil (lavendula angustifolia)

Cyprus oil ( cupressus sempervirens)

Eucalyptus blue mallee oil

Marjoram (thymus mastichina)

Rosemary oil (rosmarinus officinalis)

Juniper oil (juniperus communis)

magnesium aluminum silicate

Immortelle oil (helichysum angustifolium)

Clary sage oil (salvia sclarea)

Tea tree oil (melaleuca alternifolia)

Peppermint oil (mentha piperita)

Basil oi (ocimum basilicum)

ginger (zingiber officinale)

Benzoin (styrax benzoin resin extract )

Potassium sorbate

Sodium benzoate

Principle Display Panel 113g container

INGREDIENTS AND APPEARANCE

DREAM CREAM 
camphor, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70722-232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.45 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SWEET MARJORAM (UNII: G9Z40ZYU6P)
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GINGER (UNII: C5529G5JPQ)
WATER (UNII: 059QF0KO0R)
SAFFLOWER OIL (UNII: 65UEH262IS)
YELLOW WAX (UNII: 2ZA36H0S2V)
ARNICA MONTANA (UNII: O80TY208ZW)
CASTOR OIL (UNII: D5340Y2I9G)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYL SALICYLATE (UNII: LAV5U5022Y)
XANTHAN GUM (UNII: TTV12P4NEE)
CINNAMON OIL (UNII: E5GY4I6YCZ)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)
EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO)
ROSEMARY OIL (UNII: 8LGU7VM393)
JUNIPERUS OXYCEDRUS LEAF OIL (UNII: YNW2QPG8YK)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PSEUDOGNAPHALIUM LUTEOALBUM WHOLE (UNII: HR514FFZ7I)
CLARY SAGE (UNII: U3HSK5JC0Q)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
BASIL OIL (UNII: Z129UMU8LE)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70722-232-04	113 g in 1 CONTAINER; Type 0: Not a Combination Product	10/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/05/2016

Labeler - Little Moon Essentials (840835115)

Registrant - Little Moon Essentials (840835115)

Establishment
Name	Address	ID/FEI	Business Operations
Little Moon Essentials		840835115	manufacture(70722-232)