INSTANT COOL SKIN INSTANT RELIEF. SUDDEN RESULTS- lidocaine 0.5% lotion
Therapon Skin Health, LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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

label back

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66428-007-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/15/2015

Labeler - Therapon Skin Health, LP (792518995)