INSTANT COOL SKIN INSTANT RELIEF. SUDDEN RESULTS- lidocaine 0.5% lotion

Instant Cool Skin by

Drug Labeling and Warnings

Instant Cool Skin by is a Otc medication manufactured, distributed, or labeled by Therapon Skin Health, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 0.5%

Uses

External Analgesic

Indications

For temporary relief of pain associated with sunburn and minor skin burns.

Warnings

For external use only, avoid contact with eyes. Do not use in large quantities, particularly over raw surfaces or blistered surfaces

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

STOP USE

Stop use and ask a doctor if:

• condition worsens
• symptoms persist for more than 7 days
• condition clears up and occurs again within a few days

Directions

• Adults and children 2 years and older: apply to affected area. Do not use more than 3-4x daily. Repeat daily until healed.
• Children under 2 years of age: consult a doctor

Inactive Ingredients

Water, Ethanol, Propylene Glycol, Lactic Acid

Package Display

INGREDIENTS AND APPEARANCE

INSTANT COOL SKIN  INSTANT RELIEF. SUDDEN RESULTS
lidocaine 0.5% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66428-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LACTIC ACID (UNII: 33X04XA5AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66428-007-01	60 mL in 1 BOTTLE; 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	06/15/2015

Labeler - Therapon Skin Health, LP (792518995)