CALAMINE- calamine, pramoxine hcl lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Calamine 8%, Pramoxine HCl 1%

Available from:

United Natural Foods, Inc. dba UNFI

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin protectant External analgesic - for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac - dries the oozing and weeping of poison: - ivy - oak - sumac - condition worsens - symptoms last more than 7 days or clean up and occur again within a few days

Authorization status:

OTC monograph final

Summary of Product characteristics

CALAMINE- CALAMINE, PRAMOXINE HCL LOTION
UNITED NATURAL FOODS, INC. DBA UNFI
_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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MEDICATED CALAMINE LOTION
336.003/336AG
ACTIVE INGREDIENTS
Calamine 8%
Pramoxine HCl 1%
PURPOSE
Skin protectant
External analgesic
USE
for the temporary relief of pain and itching associated with minor
skin irritations and
rashes due to poison ivy, poison oak, or poison sumac
dries the oozing and weeping of poison:
ivy
oak
sumac
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
do not get into eyes
STOP USE AND ASK A DOCTOR
condition worsens
symptoms last more than 7 days or clean 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
shake well
before applying was affected are of skin
Adults and children 2 years of age and older - apply to affected area
not more than 3 to
4 times daily
Children under 2 years of age - do not use, ask a doctor
OTHER INFORMATION
store at room temperature (59°-77°F)
INACTIVE INGREDIENTS
alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl
methylcellulose, Lavandula
angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene
glycol,
Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum
*This product is not manufactured or distributed by Bausch Health US,
LLA, distributor
of Caladryl Lotion Calamine Plus Itch Reliever.
Distributed by UNFI
PROVIDENCE, RI 02908 USA
855-423-2630
PRINCIPAL DISPLAY PANEL
Compare to Caladryl Lotion active ingredient*
ndc 41163-536-30
EQUALINE
medicated calamine lotion
external analgesic
skin protectant
drying action plus itch relief
6 FL OZ (177 mL)
CALAMINE
calamine, pramoxine hcl lotion
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:41163-536
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
IN