MENTHOLATUM NATURAL ICE ORIGINAL- dimethicone, octinoxate, octisalate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Dimethicone 1%, Octinoxate 7.5%, Octisalate 5%

Available from:

The Mentholatum Company

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Dimethicone - Skin protectant Octinoxate - Sunscreen Octisalate - Sunscreen - helps prevent sunburn - temporarily protects chapped or cracked lips

Authorization status:

OTC monograph not final

Summary of Product characteristics

MENTHOLATUM NATURAL ICE ORIGINAL- DIMETHICONE, OCTINOXATE,
OCTISALATE OINTMENT
THE MENTHOLATUM COMPANY
_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 INGREDIENTS
Dimethicone 1%
Octinoxate 7.5%
Octisalate 5%
PURPOSE
Dimethicone - Skin protectant
Octinoxate - Sunscreen
Octisalate - Sunscreen
USES
helps prevent sunburn
temporarily protects chapped or cracked lips
WARNINGS
SKIN CANCER/SKIN AGING ALERT: Spending time in the sun increases your
risk of skin
cancer and early skin aging. This product has been shown only to
prevent sunburn, NOT
skin cancer or early skin aging.
FOR EXTERNAL USE ONLY
DO NOT USE
on damaged or broken skin
WHEN USING THIS PRODUCT
keep out of eyes. Rinse with water to remove.
STOP USE AND ASK A DOCTOR IF
rash occurs
condition worsens
symptoms last more than 7 days or clear up and occur again within a
few days
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months: ask a doctor
OTHER INFORMATION
protect this product from excessive heat and direct sun
INACTIVE INGREDIENTS
mineral oil, ozokerite, petrolatum, lanolin, fragrance, menthol
QUESTIONS?
1-877-636-2677
MON-FRI 9AM to 5PM (EST)
mentholatum.com
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
MENTHOLATUM NATURAL ICE ORIGINAL
dimethicone, octinoxate, octisalate ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:10742-3004
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
DIMETHICONE
10 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
75 mg in 1 g
OCTISALATE (