PREMIER VALUE MEDICATED BODY POWDER- menthol and zinc oxide powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Menthol 0.15% Zinc Oxide 1.0%

Available from:

Davion, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-itch Skin Protectant temporarily relieves pain and itch associated with: - minor cuts - sunburn - insect bites - rashes - scrapes - minor burns - minor skin irritations - prickly heat Dries the oozing of: - poison ivy - poison oak - poison sumac - condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Authorization status:

OTC monograph final

Summary of Product characteristics

PREMIER VALUE MEDICATED BODY POWDER- MENTHOL AND ZINC OXIDE POWDER
DAVION, 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._
----------
PREMIER VALUE MEDICATED BODY POWDER
ACTIVE INGREDIENTS
Menthol 0.15%
Zinc Oxide 1.0%
PURPOSE
Anti-itch
Skin Protectant
USES
temporarily relieves pain and itch associated with:
minor cuts
sunburn
insect bites
rashes
scrapes
minor burns
minor skin irritations
prickly heat
Dries the oozing of:
poison ivy
poison oak
poison sumac
WARNING
FOR EXTERNAL USE ONLY.
Avoid contact with eyes
STOP USE AND ASK A DOCTOR IF
condition worsens, or if symptoms persist for 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
adults and children 2 years and older apply freely up to 3 or 4 times
daily.
children under 2 years ask a doctor.
for best results, dry skin thoroughly before applying.
INACTIVE INGREDIENTS
talc, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc
stearate.
PRODUCT LABEL
PREMIER VALUE MEDICATED BODY POWDER
menthol and zinc oxide powder
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:42669-203
ROUTE OF ADMINISTRATION
TOPICAL
Davion, Inc.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
0.15 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
1 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
TALC (UNII: 7SEV7J4R1U)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SALICYLIC ACID (UNII: O414PZ4LPZ)
THYMOL (UNII: 3J50XA376E)
ZINC STEARATE (UNII: H92E6QA4FV)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:42669-
203-01
283 g in 1 CONTAINER; Type 0: Not a Combination
Product
12/05/202