CHARM-TEX ANTIPERSPIRANT ROLL ON DEODORANT- aluminum zirconium tetrachlorohydrex gly solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE)

Available from:

Charm-tex Inc.

INN (International Name):

ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY

Composition:

ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 0.3 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Antiperspirant Use: Reduce underarm perspiration

Authorization status:

OTC monograph final

Summary of Product characteristics

CHARM-TEX ANTIPERSPIRANT ROLL ON DEODORANT- ALUMINUM ZIRCONIUM
TETRACHLOROHYDREX GLY SOLUTION
CHARM-TEX 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._
----------
Active Ingredient: ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY
Purpose: Antiperspirant
Use: Reduce underarm perspiration
Warning:
For external use only
Do not use on broken skin
Stop use if rash or irritation occurs. If condition persists for more
than 72 hours consult a doctor.
Ask a doctor before use if you have kidney disease
Keep out of reach of children. If swallowed, get medical help and
contact a Poison Control Center right
away.
Directions: Apply to underarm only.
Inactive Ingredients:
Water, Glyceryl Stearate, PEG-100 Stearate, Magnisium, Aluminum,
Silicate, Fragrance.
CHARM-TEX ANTIPERSPIRANT ROLL ON DEODORANT
aluminum zirconium tetrachlorohydrex gly solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:40 0 57-0 0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALUMINUM ZIRCO NIUM TETRACHLO RO HYDREX GLY (UNII: 8 O38 6 558 JE)
(ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8 O38 6 558 JE)
ALUMINUM ZIRCONIUM
TETRACHLOROHYDREX GLY
0 .3 g
in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERYL STEARATE SE (UNII: FCZ5MH78 5I)
PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)
MAGNESIUM (UNII: I38 ZP9 9 9 2A)
ALUMINUM (UNII: CPD4NFA9 0 3)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
Charm-tex Inc.
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:40 0 57-0 0 0 1-1
44 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 7/17/20 16
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt350
0 7/17/20 16
LABELER -
Charm-tex Inc. (05834