HEALTH SMART MEDICATED BODY- menthol and zinc oxide powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

International Wholesale Inc dba Home Smart Products

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose External Analgesic Skin Protectant Uses For the temporary relief of pains and itch associated with: - Minor Cuts - Scrapes - Sunburn - Insect Bites - Prickly Heat - Rashes - Minor Burns - Minor Skin Irritation - Dries the oozing of poison ivy, oak, and sumac.

Authorization status:

OTC monograph not final

Summary of Product characteristics

HEALTH SMART MEDICATED BODY- MENTHOL AND ZINC OXIDE POWDER
INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS
_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._
----------
HEALTH SMART MEDICATED BODY POWDER
ACTIVE INGREDIENTS
Menthol 0.15%
Zinc Oxide 1.0%
PURPOS E
External Analgesic
Skin Protectant
US ES
For the temporary relief of pains and itch associated with:
Minor Cuts
Scrapes
Sunburn
Insect Bites
Prickly Heat
Rashes
Minor Burns
Minor Skin Irritation
Dries the oozing of poison ivy, oak, and sumac.
WARNINGS
FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT avoid contact with eyes.
CONSULT A DOCTOR AND DISCONTINUE USE IF
condition worsens
symptoms do not get better within 1 week or clear up and occurs again
within a few days.
KEEP OUT OF REACH OF CHILDREN
In case of accidental ingestion, seek professional assistance or
contact a Poison Control Center
immediately.
DIRECTIONS
adults and children 2 years and over
apply to the affected area not more than 3 or 4 times daily.
children under 2 years of age: consult a physician.
for best results, dry skin thoroughly before use.
INACTIVE INGREDIENTS
talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid,
thymol, zinc stearate.
PRINCIPAL DISPLAY PANEL
HEALTH SMART MEDICATED BODY POWDER
NET WT. 10 OZ. (283g)
HEALTH SMART MEDICATED BODY
menthol and zinc oxide powder
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:528 6 2-0 20
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
0 .15 g in 10 0 g
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
1 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
TALC (UNII: 7SEV7J4R1U)
ACACIA (UNII: 5C540 3N26 O)
International Wholesale Inc dba Home Smart Products
EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2