FDA Label for Anti Itch Topical Analgesic
View Indications, Usage & Precautions
Anti Itch Topical Analgesic Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Associations Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients Purpose
Diphenhydramine hydrochloride USP, 2%...................................... Antihistamine
Zinc acetate, 0.1%.................................................................... Skin protectant
Otc - Purpose
Uses
- for the temporary relief of itching and pain associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak and poison sumac
- dries the oozing and weeping of poison ivy, poison oak and poison sumac
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth
Otc - Ask Doctor
Ask a doctor before use
- on chicken pox
- on measles
Otc - When Using
When using this product avoid contact with the eyes
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or does not improve within 7 days
- symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - 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
Indications & Usage
Directions
- do not use more than directed
- adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily, or as directed by a doctor
- children under 12 years of age, consult a doctor
Storage And Handling
Other information
- store at 20° to 25°C (68° to 77°F)
- lot no. & exp. date: see box or see crimp of tube
Inactive Ingredient
inactive ingredients
cetanol, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, stearyl alcohol, purfied water
Dosage & Administration
DISTRIBUTED BY:
C.D.M.A. INC.
43157 W. NINE MILE
NOVA, MI 48376-0995
Made in Korea
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