OCEAN POTION INSTANT BURN RELIEF ICE- lidocaine gel
Sun & Skin Care Research, LLC

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.

----------

DRUG FACTS

Active Ingredient

Lidocaine 0.5%

Purpose

Temporarily Relieves pain due to:

sunburn
minor burns

Uses

Temporarily Relieves pain and itching due to:

sunburn
minor burns

Warnings

For external use only. Do not swallow. Avoid contact with eyes. If contacted, flush eyes with water. Should a rash or irritation develops, discontinue use. If condition worsens, or if symptoms persist for more than 7 days, consult a physician. Do not use in large quantities, particularly over raw surfaces or blistered areas. Keep out of the reach of children.

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.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, CI 42090, DMDM Hydantoin, Fragrance, Glycerin, Isoceteth-20, Melaleuca Alternifolia (Tea Tree Oil), Menthol, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Symphytum Officinale (Comfrey) Extract, Triethanolamine, Water

Directions

Adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age, consult a physician.

protect this product from excessive heat and direct sun
for use on skin only

image of carton label

OCEAN POTION INSTANT BURN RELIEF ICE
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62802-172
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 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOCETETH-20 (UNII: O020065R7Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
COMFREY LEAF (UNII: DG4F8T839X)
TEA TREE OIL (UNII: VIF565UC2G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62802-172-65	605 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/01/2012

Labeler - Sun & Skin Care Research, LLC (849772207)

Name	Address	ID/FEI	Business Operations
Establishment
Sun & Skin Care Research, LLC		849772207	manufacture(62802-172)