PROVON PERINEAL SKIN PROT WITH 99 PETROLATUM- petrolatum ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)

Available from:

GOJO Industries, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant Helps prevent and temporarily protects chafed, chapped, or cracked skin

Authorization status:

OTC monograph final

Summary of Product characteristics

PROVON PERINEAL SKIN PROT WITH 99 PETROLATUM- PETROLATUM OINTMENT
GOJO INDUSTRIES, 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._
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PROVON PERINEAL SKIN PROTECTANT
ACTIVE INGREDIENT
Petrolatum 99%
PURPOS E
Skin Protectant
US E
Helps prevent and temporarily protects chafed, chapped, or cracked
skin
WARNINGS
For external use only
When using this product • do not get into eyes
See a doctor if condition lasts more than 7 days
Do not use on • deep or puncture wounds • animal bites • serious
burns
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
Apply as needed
INACTIVE INGREDIENTS
Sorbitan Oleate, Tocopheryl Acetate, Fragrance (Parfum), Green 6 (CI
61565)
LABEL
PROVON PERINEAL SKIN PROT WITH 99 PETROLATUM
petrolatum ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:21749 -442
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)
PETROLATUM
0 .9 9 g in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO RBITAN MO NO O LEATE (UNII: 0 6 XEA2VD56 )
GOJO Industries, Inc.
.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
D&C GREEN NO . 6 (UNII: 4QP5U8 4YF7)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:21749 -442-0 2
57 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct
0 5/0 1/20 10
2
NDC:21749 -442-0 5
142 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct
0 5/0 1/20 10
3
NDC:21749 -442-0 7
19 9 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct
0 5/0 1/20 10
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 rt347
0 5/0 1/20 10
LABELER -
GOJO Industries, Inc. (