OTC Medication Information: Ocean Potion Instant Burn Relief Ice

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.

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
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE .5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
ISOCETETH-20
PROPYLENE GLYCOL
ALOE VERA LEAF
GLYCERIN
MENTHOL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
DMDM HYDANTOIN
PHENOXYETHANOL
METHYLPARABEN
PROPYLPARABEN
TROLAMINE
ARNICA MONTANA FLOWER
COMFREY LEAF
TEA TREE OIL
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62802-172-65 605 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/01/2012
Labeler — Sun & Skin Care Research, LLC (849772207)
Establishment
Name Address ID/FEI Operations
Sun & Skin Care Research, LLC 849772207 manufacture (62802-172)

Revised: 03/2014 Sun & Skin Care Research, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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