NATRALIA ANTI-ITCH SOOTHING- oatmeal and menthol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y), Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)

Available from:

LaCorium Health USA Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For temporary relief of pain and itching associated with minor skin irritation, cuts or scrapes and sunburn. Temporarily protects and helps relieve itching and minor skin irritations caused by: - Rashes - Eczema - Poison Ivy, Oak or Sumac - Insect Bites

Authorization status:

OTC monograph final

Summary of Product characteristics

NATRALIA ANTI-ITCH SOOTHING- OATMEAL AND MENTHOL CREAM
LACORIUM HEALTH USA INC
_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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NATRALIA™ ANTI-ITCH SOOTHING CREAM
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE _
Colloidal Oatmeal 2%
Skin
protectant
Menthol 0.6%
Topical
analgesic
US ES
For temporary relief of pain and itching associated with minor skin
irritation, cuts or scrapes and
sunburn. Temporarily protects and helps relieve itching and minor skin
irritations caused by:
Rashes
Eczema
Poison Ivy, Oak or Sumac
Insect Bites
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE on open wounds or broken skin
STOP USE AND ASK A DOCTOR IF condition worsens or does not improve
after regular use (7 days) of this
product as directed or if local irritation or rash occurs
Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with
water
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Adults and children 2 years of age and older: apply to affected area
not more than 3-4 times daily.
Children under 2 years of age: consult a doctor.
Smooth in gently
Patch test recommended on sensitive skin
OTHER INFORMATION
STORE BETWEEN 50°- 86°F IN A DRY PLACE
INACTIVE INGREDIENTS
Benzyl Alcohol, Butyrospermum Parkii (Shea Butter), Cetyl Alcohol,
Dimethicone, Disodium EDTA,
Distearyldimonium Chloride, Epilobium Angustifolium Flower/Leaf/Stem
Extract, Glyceryl Stearate
(and) PEG-100 Stearate, Hydroxyethyl Cellulose, Isopropyl Palmitate,
Jojoba Esters, Phenoxyethanol,
Sodium Hydroxide, Sodium Metabisulfite, Stearyl Alcohol (and)
Ceteareth-20, Theobrome Cacao
(Cocoa) Seed Butter, Water
QUESTIONS OR COMMENTS?
Call Toll Free 1-877-687-2542
US [e-mail]
WWW.NATRALIA.COM
PRINCIPAL DISPLAY PANEL - 85 G TUBE CARTON
NDC: 43251-3345-1
natralia™
NATURALLY AUSTRALIAN
Anti-Itch
Soothing
Cream
SOOTHES & R